The following data is part of a premarket notification filed by Itamar Medical Ltd with the FDA for Watch-pat200u (wp200u).
| Device ID | K133859 |
| 510k Number | K133859 |
| Device Name: | WATCH-PAT200U (WP200U) |
| Classification | Ventilatory Effort Recorder |
| Applicant | ITAMAR MEDICAL LTD 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Contact | Jonathan Kahan, Esq |
| Correspondent | Jonathan Kahan, Esq 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 | 2013-12-19 |
| Decision Date | 2014-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109222899 | K133859 | 000 |
| 07290109222011 | K133859 | 000 |
| 07290109222035 | K133859 | 000 |
| 07290109222059 | K133859 | 000 |
| 07290109222073 | K133859 | 000 |
| 07290109222080 | K133859 | 000 |
| 07290109222097 | K133859 | 000 |
| 07290109222523 | K133859 | 000 |
| 07290109222646 | K133859 | 000 |
| 07290109222691 | K133859 | 000 |
| 07290109222738 | K133859 | 000 |
| 07290109222844 | K133859 | 000 |
| 07290109222103 | K133859 | 000 |