The following data is part of a premarket notification filed by Salter Labs with the FDA for Oxygen Mask, Air-entrainment.
| Device ID | K772127 |
| 510k Number | K772127 |
| Device Name: | OXYGEN MASK, AIR-ENTRAINMENT |
| Classification | Mask, Oxygen, Low Concentration, Venturi |
| Applicant | SALTER LABS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYF |
| CFR Regulation Number | 868.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-11 |
| Decision Date | 1978-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607411889841 | K772127 | 000 |
| 10607411302029 | K772127 | 000 |
| 10607411300704 | K772127 | 000 |