FLYNN SERIES III BAG/MASK UNIT-

Ventilator, Emergency, Manual (resuscitator)

O-TWO SYSTEMS INTL., INC.

The following data is part of a premarket notification filed by O-two Systems Intl., Inc. with the FDA for Flynn Series Iii Bag/mask Unit-.

Pre-market Notification Details

Device IDK832495
510k NumberK832495
Device Name:FLYNN SERIES III BAG/MASK UNIT-
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant O-TWO SYSTEMS INTL., INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-27
Decision Date1983-09-29

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