The following data is part of a premarket notification filed by Cook Pacemaker Corp. with the FDA for Cook Pacemaker Corp. 115 Unipolar Cardi.
| Device ID | K842081 |
| 510k Number | K842081 |
| Device Name: | COOK PACEMAKER CORP. 115 UNIPOLAR CARDI |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | COOK PACEMAKER CORP. 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 | 1984-05-23 |
| Decision Date | 1984-07-06 |