The following data is part of a premarket notification filed by O-two Medical Technologies, Inc. with the FDA for Carevent Handheld Cpap System.
| Device ID | K093862 |
| 510k Number | K093862 |
| Device Name: | CAREVENT HANDHELD CPAP SYSTEM |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | O-TWO MEDICAL TECHNOLOGIES, INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8 |
| Contact | David Zhang |
| Correspondent | David Zhang O-TWO MEDICAL TECHNOLOGIES, INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-17 |
| Decision Date | 2010-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540195036000 | K093862 | 000 |