The following data is part of a premarket notification filed by O-two Medical Technologies, Inc. with the FDA for Carevent Par (public Access Resuscitator).
| Device ID | K081330 |
| 510k Number | K081330 |
| Device Name: | CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR) |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | O-TWO MEDICAL TECHNOLOGIES, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden O-TWO MEDICAL TECHNOLOGIES, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-12 |
| Decision Date | 2009-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540195025332 | K081330 | 000 |