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 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 |
NIH GUDID Devices
| 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 |
Trademark Results [RESCUE BREATHER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESCUE BREATHER 75918682 not registered Dead/Abandoned |
O-TWO SYSTEMS INTERNATIONAL, INC. 2000-02-14 |
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