K131994 is an FDA 510(k) clearance for the SOMNOLYZER 24X7. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on October 17, 2013, 111 days after receiving the submission on June 28, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K131994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2013 |
| Decision Date | October 17, 2013 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MNR — Ventilatory Effort Recorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |