ZOLL REVIVER

Automated External Defibrillators (non-wearable)

ZOLL MEDICAL CORP.

The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll Reviver.

Pre-market Notification Details

Device IDK972241
510k NumberK972241
Device Name:ZOLL REVIVER
ClassificationAutomated External Defibrillators (non-wearable)
Applicant ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington,  MA  01803
ContactMaura Mcguire
CorrespondentMaura Mcguire
ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington,  MA  01803
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-16
Decision Date1998-03-16

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