The following data is part of a premarket notification filed by Cardinal Health 207, Inc. with the FDA for Puresom Nasal Mask-small, Puresom Nasal Mask-medium, Puresom Nasal Mask-large, Models 11924-01, 11924-02, 11924-03.
| Device ID | K093124 |
| 510k Number | K093124 |
| Device Name: | PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | CARDINAL HEALTH 207, INC. 22745 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Monther Abushaban |
| Correspondent | Monther Abushaban CARDINAL HEALTH 207, INC. 22745 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-02 |
| Decision Date | 2010-03-10 |
| Summary: | summary |