AUTOMATIC VENTILATOR AV2000

Ventilator, Emergency, Powered (resuscitator)

LIFE SUPPORT PRODUCTS, INC.

The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for Automatic Ventilator Av2000.

Pre-market Notification Details

Device IDK874656
510k NumberK874656
Device Name:AUTOMATIC VENTILATOR AV2000
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine,  CA  92718
ContactTom Fangrow
CorrespondentTom Fangrow
LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine,  CA  92718
Product CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-19
Decision Date1988-01-19

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