K161579 is an FDA 510(k) clearance for the Watch-PAT200U. This device is classified as a Ventilatory Effort Recorder (Class II - Special Controls, product code MNR).
Submitted by Itamar Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on February 24, 2017, 262 days after receiving the submission on June 7, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K161579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2016 |
| Decision Date | February 24, 2017 |
| Days to Decision | 262 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 |