AUTOVENT 1500

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 Autovent 1500.

Pre-market Notification Details

Device IDK983857
510k NumberK983857
Device Name:AUTOVENT 1500
ClassificationVentilator, Emergency, Powered (resuscitator)
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 CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-02
Decision Date1998-11-04
Summary:summary

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