FLYNNR GENESIS II A/C, A/O AND IDLH

Ventilator, Emergency, Powered (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 Flynnr Genesis Ii A/c, A/o And Idlh.

Pre-market Notification Details

Device IDK932170
510k NumberK932170
Device Name:FLYNNR GENESIS II A/C, A/O AND IDLH
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST. Mississauga, Ontario,  CA L5s 1c8
ContactKevin Bowden
CorrespondentKevin Bowden
O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST. Mississauga, Ontario,  CA L5s 1c8
Product CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-04
Decision Date1993-10-25

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