LIFESAVER, MANUAL #5160

Ventilator, Emergency, Manual (resuscitator)

HUDSON OXYGEN THERAPY SALES CO.

The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Lifesaver, Manual #5160.

Pre-market Notification Details

Device IDK780216
510k NumberK780216
Device Name:LIFESAVER, MANUAL #5160
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant HUDSON OXYGEN THERAPY SALES CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-02-10
Decision Date1978-03-14

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