The following data is part of a premarket notification filed by Salter Labs with the FDA for Demand Nasal Oxygen Cannula Models 4008/4108/4208.
| Device ID | K890298 |
| 510k Number | K890298 |
| Device Name: | DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208 |
| Classification | Conserver, Oxygen |
| Applicant | SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
| Contact | James N Curti |
| Correspondent | James N Curti SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-19 |
| Decision Date | 1989-02-23 |