The following data is part of a premarket notification filed by Itamar Medical, Ltd. with the FDA for Watch-pat200u.
| Device ID | K161579 |
| 510k Number | K161579 |
| Device Name: | Watch-PAT200U |
| 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 13th 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 | 2016-06-07 |
| Decision Date | 2017-02-24 |
| Summary: | summary |