K900113 is an FDA 510(k) clearance for the RESPIRONICS' REMSTAR(TM) SLEEPEASY. This device is classified as a Attachment, Breathing, Positive End Expiratory Pressure (Class II - Special Controls, product code BYE).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on March 28, 1990, 78 days after receiving the submission on January 9, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5965.
| 510(k) Number | K900113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1990 |
| Decision Date | March 28, 1990 |
| Days to Decision | 78 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 |