IMPACT MODELS 701, 702 AND 703

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 Models 701, 702 And 703.

Pre-market Notification Details

Device IDK861272
510k NumberK861272
Device Name:IMPACT MODELS 701, 702 AND 703
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant IMPACT INSTRUMENTATION, INC. P.O. BOX 412 Bogota,  NJ  07603
ContactLeslie H Sherman
CorrespondentLeslie H Sherman
IMPACT INSTRUMENTATION, INC. P.O. BOX 412 Bogota,  NJ  07603
Product CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-04
Decision Date1986-05-20

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