FLLYNN(R) GENESIS AC

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 Fllynn(r) Genesis Ac.

Pre-market Notification Details

Device IDK913039
510k NumberK913039
Device Name:FLLYNN(R) GENESIS AC
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST. Mississauga, Ontario,  CA L5s 1c8
ContactJoe Lassaline
CorrespondentJoe Lassaline
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 Received1991-07-09
Decision Date1992-08-25

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