Atlas FDA

STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES

FDA 510(k) clearance K943698 · decided 1994-12-28

Clearance details

K-number
K943698
Device name
STAT PADZ STERILE ADULT MULTI-FUNCTION ELECTRODES
Applicant
Zoll Medical Corp
Decision
Substantially Equivalent
Date received
1994-07-29
Decision date
1994-12-28
Days to decision
152 days
Clearance type
Traditional
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Burlington, MA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

RecordFirmDate
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage recall (Z-0052-2015)Bio-Detek, Inc.2014-10-09
ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Produ recall (Z-0053-2015)Bio-Detek, Inc.2014-10-09
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part numb recall (Z-0054-2015)Bio-Detek, Inc.2014-10-09
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single recall (Z-0055-2015)Bio-Detek, Inc.2014-10-09
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Ele recall (Z-2658-2014)Bio-Detek, Inc.2014-09-17
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 Th recall (Z-2659-2014)Bio-Detek, Inc.2014-09-17
ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part numb recall (Z-2660-2014)Bio-Detek, Inc.2014-09-17