The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Labs Infant Medium Concentration Mask.
| Device ID | K912633 |
| 510k Number | K912633 |
| Device Name: | SALTER LABS INFANT MEDIUM CONCENTRATION MASK |
| Classification | Mask, 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 | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-14 |
| Decision Date | 1991-07-19 |