The following data is part of a premarket notification filed by Itamar Medical with the FDA for Watch-pat 200i (wp200i).
| Device ID | K081037 |
| 510k Number | K081037 |
| Device Name: | WATCH-PAT 200I (WP200I) |
| Classification | Ventilatory Effort Recorder |
| Applicant | ITAMAR MEDICAL 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Johathan S Kahan |
| Correspondent | Johathan S Kahan ITAMAR MEDICAL 555 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 | 2008-04-11 |
| Decision Date | 2008-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109222981 | K081037 | 000 |
| 07290109222974 | K081037 | 000 |
| 07290109222929 | K081037 | 000 |
| 07290109222912 | K081037 | 000 |
| 07290109222868 | K081037 | 000 |
| 07290109222851 | K081037 | 000 |
| 07290109220031 | K081037 | 000 |
| 07290109222592 | K081037 | 000 |
| 07290109222004 | K081037 | 000 |