PPM III

Valve, Non-rebreathing

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 Ppm Iii.

Pre-market Notification Details

Device IDK940712
510k NumberK940712
Device Name:PPM III
ClassificationValve, Non-rebreathing
Applicant O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST., UNIT 5 MISSISSAUGA Ontario L5s 1c8,  CA
ContactKevin Bowden
CorrespondentKevin Bowden
O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST., UNIT 5 MISSISSAUGA Ontario L5s 1c8,  CA
Product CodeCBP  
CFR Regulation Number868.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-17
Decision Date1994-11-14

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