The following data is part of a premarket notification filed by Itamar Medical (c.m.) 1997 Ltd. with the FDA for Sleep Pat 200 Device.
| Device ID | K010156 |
| 510k Number | K010156 |
| Device Name: | SLEEP PAT 200 DEVICE |
| Classification | Ventilatory Effort Recorder |
| Applicant | ITAMAR MEDICAL (C.M.) 1997 LTD. 377 ROUTE 17 Hasbrouck Heights, NJ 07604 |
| Contact | George H Myers |
| Correspondent | George H 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 | 2001-01-16 |
| Decision Date | 2002-06-19 |