FLYNN III-CHILD BAG-MASK UNIT ETC

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 Iii-child Bag-mask Unit Etc.

Pre-market Notification Details

Device IDK834400
510k NumberK834400
Device Name:FLYNN III-CHILD BAG-MASK UNIT ETC
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant O-TWO SYSTEMS INTL., INC. 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 Received1983-12-14
Decision Date1984-01-13

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