K112822 is an FDA 510(k) clearance for the SLEEPSTRIP II. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by S.L.P. , Ltd. (Tel-Aviv, IL). The FDA issued a Cleared decision on December 27, 2011, 90 days after receiving the submission on September 28, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K112822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2011 |
| Decision Date | December 27, 2011 |
| Days to Decision | 90 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 |