The following data is part of a premarket notification filed by Omikron Scientific, Ltd. with the FDA for Omikron Pacemaker 837 Unipolar & 838 Bipolar.
| Device ID | K844277 |
| 510k Number | K844277 |
| Device Name: | OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | OMIKRON SCIENTIFIC, LTD. KIRYAT WEIZMANN P.O.B. 2012, REHOVOT 76120 Israel, IL |
| Contact | Sandord Brown |
| Correspondent | Sandord Brown OMIKRON SCIENTIFIC, LTD. KIRYAT WEIZMANN P.O.B. 2012, REHOVOT 76120 Israel, IL |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-05 |
| Decision Date | 1985-02-15 |