The following data is part of a premarket notification filed by Itamar Medical, Ltd. with the FDA for Watch-pat300.
| Device ID | K180775 |
| 510k Number | K180775 |
| Device Name: | Watch-PAT300 |
| Classification | Ventilatory Effort Recorder |
| Applicant | Itamar Medical, Ltd. 9 Halamish St. Caesarea, IL 3088900 |
| Contact | Koby Sheffy |
| Correspondent | Jonathan Kahan Hogan Lovells US, LLP 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-23 |
| Decision Date | 2018-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109222417 | K180775 | 000 |
| 07290109222462 | K180775 | 000 |
| 07290109222486 | K180775 | 000 |
| 07290109223193 | K180775 | 000 |