The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Labs Cpap High Flow Cannula System.
| Device ID | K040202 |
| 510k Number | K040202 |
| Device Name: | SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SALTER LABS 100 W. SYCAMORE RD. Arvin, CA 93203 |
| Contact | Duane Kazal |
| Correspondent | Duane Kazal SALTER LABS 100 W. SYCAMORE RD. Arvin, CA 93203 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-29 |
| Decision Date | 2005-03-04 |
| Summary: | summary |