Atlas FDA

ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES

FDA 510(k) clearance K051076 · decided 2005-05-13

Clearance details

K-number
K051076
Device name
ZOLL STAT*PADZ MWP MULTI-FUNCTION ELECTRODES
Applicant
ZOLL Medical Corporation
Decision
Substantially Equivalent
Date received
2005-04-27
Decision date
2005-05-13
Days to decision
16 days
Clearance type
Special
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Chelsmford, MA, US
Third-party review
No
Expedited review
No

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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
ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes recall (Z-2334-2008)Bio-Detek, Inc.2008-09-20

PMA approvals by this applicant

RecordFirmDate
OneStep CPR Complete Electrode (P160022/S049)ZOLL Medical Corporation2025-12-30
AED 3™ (P160015/S025)ZOLL Medical Corporation2025-12-18
X Series®; Propaq MD®; AED 3™ BLS; Zenix Professional Defibrillators (P160022/S046)ZOLL Medical Corporation2025-12-18
ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci (P160022/S048)ZOLL Medical Corporation2025-12-09
ZOLL Zenix® Monitor/Defibrillator (P160022/S036)ZOLL Medical Corporation2025-09-29
CPR Uni-padz Electrode (P160022/S047)ZOLL Medical Corporation2025-09-22
CPR-D-padz Electrode (P160015/S026)ZOLL Medical Corporation2025-09-22
AED Plus, AED 3, X Series, R Series, Propaq MD, AED Pro, AED 3 BLS (P160022/S042)ZOLL Medical Corporation2025-08-28