POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE

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 Powered Ventilator, Lever I/ii, Battlefield Use.

Pre-market Notification Details

Device IDK905697
510k NumberK905697
Device Name:POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant IMPACT INSTRUMENTATION, INC. P.O. BOX 508 West Caldwell,  NJ  07006
ContactLeslie H Sherman
CorrespondentLeslie H 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 Received1990-12-24
Decision Date1990-12-27

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