The following data is part of a premarket notification filed by O-two Systems Intl., Inc. with the FDA for Rescue Breather.
Device ID | K940927 |
510k Number | K940927 |
Device Name: | RESCUE BREATHER |
Classification | Device, Cpr Assist |
Applicant | O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8 |
Contact | Kevin Bowden |
Correspondent | Kevin Bowden O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8 |
Product Code | LYM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-28 |
Decision Date | 1994-10-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17540195055077 | K940927 | 000 |
17540195055060 | K940927 | 000 |
07540195055056 | K940927 | 000 |
17540195055046 | K940927 | 000 |
07540195055032 | K940927 | 000 |
07540195055025 | K940927 | 000 |
07540195055018 | K940927 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RESCUE BREATHER 75918682 not registered Dead/Abandoned |
O-TWO SYSTEMS INTERNATIONAL, INC. 2000-02-14 |