Atlas FDA

POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)

FDA 510(k) clearance K052161 · decided 2005-10-21

Clearance details

K-number
K052161
Device name
POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)
Applicant
Cardiac Science, Inc.
Decision
Substantially Equivalent
Date received
2005-08-09
Decision date
2005-10-21
Days to decision
73 days
Clearance type
Special
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Powerheart Automated External Defibrillator (AED), G3 is indicated for emergency treatment recall (Z-3265-2011)Cardiac Science Corporation2011-09-19
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
GE Responder 2019198 AED Manufactured for GE Medical Systems Information Technologies by C recall (Z-0922-2009)Cardiac Science Corporation2009-02-25