K843889 is an FDA 510(k) clearance for the RESPIRONICS SLEEPEASY NASAL CPAP SYS. 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 December 4, 1984, 63 days after receiving the submission on October 2, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5965.
| 510(k) Number | K843889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 1984 |
| Decision Date | December 04, 1984 |
| Days to Decision | 63 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 |