The following data is part of a premarket notification filed by Itamar Medical with the FDA for Watch-pat 200s-2 (wp200s-2).
| Device ID | K081982 |
| 510k Number | K081982 |
| Device Name: | WATCH-PAT 200S-2 (WP200S-2) |
| Classification | Ventilatory Effort Recorder |
| Applicant | ITAMAR MEDICAL 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan 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 | 2008-07-11 |
| Decision Date | 2008-08-14 |
| Summary: | summary |