The following data is part of a premarket notification filed by Cardinal Health 207, Inc. with the FDA for The Advantage Series Non-vented (nv) Full Face Mask.
| Device ID | K081670 |
| 510k Number | K081670 |
| Device Name: | THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-13 |
| Decision Date | 2008-10-09 |
| Summary: | summary |