The following data is part of a premarket notification filed by Omikron Scientific, Ltd. with the FDA for Lithium Pacemaker 811-811l & 811xl.
| Device ID | K840748 |
| 510k Number | K840748 |
| Device Name: | LITHIUM PACEMAKER 811-811L & 811XL |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | OMIKRON SCIENTIFIC, LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-23 |
| Decision Date | 1984-08-03 |