IMPACT MODEL 753

Ventilator, Emergency, Powered (resuscitator)

IMPACT INSTRUMENTATION, INC.

The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Impact Model 753.

Pre-market Notification Details

Device IDK931473
510k NumberK931473
Device Name:IMPACT MODEL 753
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant IMPACT INSTRUMENTATION, INC. P.O. BOX 508 West Caldwell,  NJ  07006
ContactLeslie Sherman
CorrespondentLeslie Sherman
IMPACT INSTRUMENTATION, INC. P.O. BOX 508 West Caldwell,  NJ  07006
Product CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-24
Decision Date1994-12-30

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