K042253 is an FDA 510(k) clearance for the SLEEPSENSE SLEEP SENSORS. 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 October 6, 2004, 47 days after receiving the submission on August 20, 2004.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K042253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2004 |
| Decision Date | October 06, 2004 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | MNR — Ventilatory Effort Recorder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |