The following data is part of a premarket notification filed by Itamar Medical Ltd with the FDA for Watch-pat 200s-3 (wp200s-3).
| Device ID | K102567 |
| 510k Number | K102567 |
| Device Name: | WATCH-PAT 200S-3 (WP200S-3) |
| Classification | Ventilatory Effort Recorder |
| Applicant | ITAMAR MEDICAL LTD 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Contact | Jonathan Kahn |
| Correspondent | Jonathan Kahn ITAMAR MEDICAL LTD 555 THIRTEENTH 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 | 2010-09-07 |
| Decision Date | 2011-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109222936 | K102567 | 000 |
| 07290109222875 | K102567 | 000 |
| 07290109222653 | K102567 | 000 |
| 07290109222615 | K102567 | 000 |