K102567 is an FDA 510(k) clearance for the WATCH-PAT 200S-3 (WP200S-3). This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Itamar Medical , Ltd. (Washington, US). The FDA issued a Cleared decision on June 2, 2011, 268 days after receiving the submission on September 7, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K102567 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2010 |
| Decision Date | June 02, 2011 |
| Days to Decision | 268 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 |