The following data is part of a premarket notification filed by Itamar Medical (c.m.) 1997 Ltd. with the FDA for Watch-pat 100.
| Device ID | K010739 |
| 510k Number | K010739 |
| Device Name: | WATCH-PAT 100 |
| Classification | Ventilatory Effort Recorder |
| Applicant | ITAMAR MEDICAL (C.M.) 1997 LTD. 377 ROUTE 17 Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers ITAMAR MEDICAL (C.M.) 1997 LTD. 377 ROUTE 17 Hasbrouck Heights, NJ 07604 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-12 |
| Decision Date | 2001-11-06 |