The following data is part of a premarket notification filed by Cardinal Health 207, Inc. with the FDA for Avea Ventilator.
| Device ID | K081837 |
| 510k Number | K081837 |
| Device Name: | AVEA VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | CARDINAL HEALTH 207, INC. 22745 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Andre Von Muller |
| Correspondent | Andre Von Muller CARDINAL HEALTH 207, INC. 22745 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-30 |
| Decision Date | 2008-08-13 |
| Summary: | summary |