UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+

Ventilator, Continuous, Facility Use

IMPACT INSTRUMENTATION, INC.

The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Uni-vent-731 Series Ventilators, Model 731emv+.

Pre-market Notification Details

Device IDK091238
510k NumberK091238
Device Name:UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
ClassificationVentilator, Continuous, Facility Use
Applicant IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. West Caldwell,  NJ  07006 -0508
ContactLeslie H Sherman
CorrespondentLeslie H Sherman
IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. West Caldwell,  NJ  07006 -0508
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-27
Decision Date2009-08-13
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.