The following data is part of a premarket notification filed by O-two Medical Technologies, Inc. with the FDA for Carevent Atv+ And Carevent Mri.
| Device ID | K051469 |
| 510k Number | K051469 |
| Device Name: | CAREVENT ATV+ AND CAREVENT MRI |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | O-TWO MEDICAL TECHNOLOGIES, INC. 7575 KIMBEL ST. Mississauga, Ontario, CA L5s 1c8 |
| Contact | Ammar Al-dojally |
| Correspondent | Ammar Al-dojally 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 | 2005-06-03 |
| Decision Date | 2005-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540195030183 | K051469 | 000 |