The following data is part of a premarket notification filed by Itamar Medical, Ltd with the FDA for Watchpat300 (wp300).
| Device ID | K222331 |
| 510k Number | K222331 |
| Device Name: | WatchPAT300 (WP300) |
| Classification | Ventilatory Effort Recorder |
| Applicant | Itamar Medical, Ltd 9 Halamish Street Casearea, IL 3088900 |
| Contact | Efrat Litman |
| Correspondent | Jonathan Kahan Hogan Lovells Us Llp 553 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-02 |
| Decision Date | 2022-09-14 |