IMPULSE 3000 DEFIBRILLATOR ANALYZER

Tester, Defibrillator

DYNATECH/NEVADA, INC.

The following data is part of a premarket notification filed by Dynatech/nevada, Inc. with the FDA for Impulse 3000 Defibrillator Analyzer.

Pre-market Notification Details

Device IDK934254
510k NumberK934254
Device Name:IMPULSE 3000 DEFIBRILLATOR ANALYZER
ClassificationTester, Defibrillator
Applicant DYNATECH/NEVADA, INC. 555 THIRTEENTH ST. N.W. Washington,  DC  20004 -1109
ContactHoward M Holstein
CorrespondentHoward M Holstein
DYNATECH/NEVADA, INC. 555 THIRTEENTH ST. N.W. Washington,  DC  20004 -1109
Product CodeDRL  
CFR Regulation Number870.5325 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-31
Decision Date1993-11-23

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