The following data is part of a premarket notification filed by Itamar Medical (c.m.) 1997 Ltd. with the FDA for Peripheral Arterial Tonometer-pat 1000rd Device.
| Device ID | K001852 |
| 510k Number | K001852 |
| Device Name: | PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | ITAMAR MEDICAL (C.M.) 1997 LTD. P.O.B. 454 Ginot Shomron 44853, IL 44853 |
| Contact | Ahava Stein |
| Correspondent | Ahava Stein ITAMAR MEDICAL (C.M.) 1997 LTD. P.O.B. 454 Ginot Shomron 44853, IL 44853 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-19 |
| Decision Date | 2001-02-21 |