K810991 is an FDA 510(k) clearance for the HEADSTRAP. This device is classified as a Strap, Head, Gas Mask (Class I - General Controls, product code BTK).
Submitted by Respironics, Inc. (Monroeville, US). The FDA issued a Cleared decision on April 29, 1981, 16 days after receiving the submission on April 13, 1981.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5560.
| 510(k) Number | K810991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 1981 |
| Decision Date | April 29, 1981 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BTK — Strap, Head, Gas Mask |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5560 |