K851396 is an FDA 510(k) clearance for the SANDER'S MASKCPAP BY RESPIRONICS. This device is classified as a Attachment, Breathing, Positive End Expiratory Pressure (Class II - Special Controls, product code BYE).
Submitted by Respironics, Inc. (Monroeville, US). The FDA issued a Cleared decision on May 15, 1985, 36 days after receiving the submission on April 9, 1985.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5965.
| 510(k) Number | K851396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1985 |
| Decision Date | May 15, 1985 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BYE — Attachment, Breathing, Positive End Expiratory Pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5965 |