The following data is part of a premarket notification filed by O-two Medical Technologies, Inc. with the FDA for O_two Cpap System.
| Device ID | K112546 |
| 510k Number | K112546 |
| Device Name: | O_TWO CPAP SYSTEM |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | O-TWO MEDICAL TECHNOLOGIES, INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8 |
| Contact | Ammar Al-dojaily |
| Correspondent | Ammar Al-dojaily O-TWO MEDICAL TECHNOLOGIES, INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-01 |
| Decision Date | 2011-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540195035147 | K112546 | 000 |
| 17540195035031 | K112546 | 000 |
| 07540195035058 | K112546 | 000 |
| 17540195035062 | K112546 | 000 |
| 17540195035079 | K112546 | 000 |
| 17540195035086 | K112546 | 000 |
| 17540195035093 | K112546 | 000 |
| 17540195035109 | K112546 | 000 |
| 17540195035116 | K112546 | 000 |
| 07540195035126 | K112546 | 000 |
| 17540195035130 | K112546 | 000 |
| 17540195035024 | K112546 | 000 |