RESCUE BREATHER

Device, Cpr Assist

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 Rescue Breather.

Pre-market Notification Details

Device IDK940927
510k NumberK940927
Device Name:RESCUE BREATHER
ClassificationDevice, Cpr Assist
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 CodeLYM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-28
Decision Date1994-10-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17540195055077 K940927 000
17540195055060 K940927 000
07540195055056 K940927 000
17540195055046 K940927 000
07540195055032 K940927 000
07540195055025 K940927 000
07540195055018 K940927 000

Trademark Results [RESCUE BREATHER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RESCUE BREATHER
RESCUE BREATHER
75918682 not registered Dead/Abandoned
O-TWO SYSTEMS INTERNATIONAL, INC.
2000-02-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.