ZOLL AUTOCLAVABLE INTERNAL HANDLES

Dc-defibrillator, Low-energy, (including Paddles)

ZOLL MEDICAL CORP.

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

Pre-market Notification Details

Device IDK032691
510k NumberK032691
Device Name:ZOLL AUTOCLAVABLE INTERNAL HANDLES
ClassificationDc-defibrillator, Low-energy, (including Paddles)
Applicant ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford,  MA  01824 -4105
ContactPaul Dias
CorrespondentPaul Dias
ZOLL MEDICAL CORP. 269 MILL ROAD Chelmsford,  MA  01824 -4105
Product CodeLDD  
CFR Regulation Number870.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-02
Decision Date2003-11-13

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