The following data is part of a premarket notification filed by Cook Pacemaker Corp. with the FDA for Bipolar Cardiac Pulse Generator With Telemetry.
| Device ID | K854919 |
| 510k Number | K854919 |
| Device Name: | BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY |
| Classification | Implantable Pacemaker Pulse-generator |
| Applicant | COOK PACEMAKER CORP. P.O. BOX 529 Leechburg, PA 15656 |
| Contact | Richard W Shirley |
| Correspondent | Richard W Shirley COOK PACEMAKER CORP. P.O. BOX 529 Leechburg, PA 15656 |
| Product Code | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-09 |
| Decision Date | 1985-12-19 |