K991788 is an FDA 510(k) clearance for the SALTER LABS PEP DEVICE. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on August 6, 1999, 73 days after receiving the submission on May 25, 1999.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K991788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 1999 |
| Decision Date | August 06, 1999 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |