The following data is part of a premarket notification filed by Itamar Medical, Ltd. with the FDA for Watchpat One.
| Device ID | K183559 |
| 510k Number | K183559 |
| Device Name: | WatchPAT ONE |
| Classification | Ventilatory Effort Recorder |
| Applicant | Itamar Medical, Ltd. 9 Halamish St. Caesarea, IL |
| Contact | Koby Sheffy |
| Correspondent | Jonathan Kahan Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 -1109 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-20 |
| Decision Date | 2019-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109222424 | K183559 | 000 |
| 07290109223032 | K183559 | 000 |
| 07290109223025 | K183559 | 000 |
| 07290109223254 | K183559 | 000 |
| 07290109223230 | K183559 | 000 |
| 07290109223223 | K183559 | 000 |