Atlas FDA

POWERHEART AED G3, MODEL 9300

FDA 510(k) clearance K031987 · decided 2003-07-30

Clearance details

K-number
K031987
Device name
POWERHEART AED G3, MODEL 9300
Applicant
Cardiac Science
Decision
Substantially Equivalent
Date received
2003-06-27
Decision date
2003-07-30
Days to decision
33 days
Clearance type
Special
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Edina, MN, US
Third-party review
No
Expedited review
No

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LIFEPAK 15 monitor/defibrillator (K142430)Physio-Control, Inc.2014-12-19
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ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY (K141231)Zeller Power Products (Battery Beast, LLC)2014-11-25
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Recalls involving this device

RecordFirmDate
Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following m recall (Z-1057-2012)Cardiac Science Corporation2012-02-27
Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment recall (Z-3265-2011)Cardiac Science Corporation2011-09-19
Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic mo recall (Z-1810-2010)Cardiac Science Corporation2010-06-21
Cardiac Science, Automated External Defibrillator (AED) under the following brand names (w recall (Z-1424-2010)Cardiac Science Corporation2010-04-27
Powerheart 9300A automated external defibrillator. This fully automatic model does not req recall (Z-1243-2010)Cardiac Science Corporation2010-04-06
Powerheart 9300E automated external defibrillator. This semi-automatic model requires the recall (Z-1244-2010)Cardiac Science Corporation2010-04-06
Powerheart 9300P automated external defibrillator. This semi-automatic model requires the recall (Z-1245-2010)Cardiac Science Corporation2010-04-06
Powerheart 9390A automated external defibrillator. This fully automatic model does not req recall (Z-1246-2010)Cardiac Science Corporation2010-04-06
Powerheart 9390E automated external defibrillator. This semi-automatic model requires the recall (Z-1247-2010)Cardiac Science Corporation2010-04-06
Responder 2023440 automated external defibrillator. This semi-automatic model requires the recall (Z-1248-2010)Cardiac Science Corporation2010-04-06
Cardiovive 92532 automated external defibrillator. This semi-automatic model requires the recall (Z-1249-2010)Cardiac Science Corporation2010-04-06
Cardiac Science Powerheart 9300A automated external defibrillator. This fully automatic mo recall (Z-0765-2010)Cardiac Science Corporation2010-03-04
Cardiac Science Powerheart 9300C automated external defibrillator. This semi-automatic mod recall (Z-0766-2010)Cardiac Science Corporation2010-03-04
Cardiac Science Powerheart 9300D automated external defibrillator. This semi-automatic mod recall (Z-0767-2010)Cardiac Science Corporation2010-03-04
Cardiac Science Powerheart 9300E automated external defibrillator. This semi-automatic mod recall (Z-0768-2010)Cardiac Science Corporation2010-03-04
Cardiac Science Powerheart 9300P automated external defibrillator. This semi-automatic mod recall (Z-0769-2010)Cardiac Science Corporation2010-03-04
Cardiac Science Powerheart 9390A automated external defibrillator. This fully automatic mo recall (Z-0770-2010)Cardiac Science Corporation2010-03-04
Cardiac Science Powerheart 9390E automated external defibrillator. This semi-automatic mod recall (Z-0771-2010)Cardiac Science Corporation2010-03-04
Burdick Cardiovive 92531 automated external defibrillator. This semi-automatic model requi recall (Z-0772-2010)Cardiac Science Corporation2010-03-04
Burdick Cardiovive 92532 automated external defibrillator. This semi-automatic model requi recall (Z-0773-2010)Cardiac Science Corporation2010-03-04
Burdick Cardiovive 92533 automated external defibrillator. This semi-automatic model requi recall (Z-0774-2010)Cardiac Science Corporation2010-03-04
GE Responder 2019198 automated external defibrillator. This semi-automatic model requires recall (Z-0775-2010)Cardiac Science Corporation2010-03-04
GE Responder 2023440 automated external defibrillator. This semi-automatic model requires recall (Z-0776-2010)Cardiac Science Corporation2010-03-04
NK 9231 CardioLife automated external defibrillator. This semi-automatic model requires th recall (Z-0777-2010)Cardiac Science Corporation2010-03-04
NK 9200G. CardioLife automated external defibrillator. This semi-automatic model requires recall (Z-0778-2010)Cardiac Science Corporation2010-03-04
Cardiac Science Powerheart Automated External Defibrillator G3 9300A recall (Z-0916-2009)Cardiac Science Corporation2009-02-25
Cardiac Science First Save Automated External Defibrillator G3 9300C recall (Z-0917-2009)Cardiac Science Corporation2009-02-25
Cardiac Science Powerheart Automated External Defibrillator G3 9300E. recall (Z-0918-2009)Cardiac Science Corporation2009-02-25
Cardiac Science Powerheart Automated External Defibrillator G3 9390A recall (Z-0919-2009)Cardiac Science Corporation2009-02-25
Cardiac Science Powerheart Automated External Defibrillator G3 9390E recall (Z-0920-2009)Cardiac Science Corporation2009-02-25
Powerheart AED G3 Automated External Defibrillator Model 9300E. Cardiac Science AEDs are m recall (Z-0398-05)Cardiac Science, Inc.2005-01-15
Power Heart AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model recall (Z-0990-04)Cardiac Science, Inc.2004-07-20
FirstSave AED G3 Automated External Defibrillator IntelliSense (Lithium) Battery, Model 91 recall (Z-0991-04)Cardiac Science, Inc.2004-07-20