K905403 is an FDA 510(k) clearance for the MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER. This device is classified as a Implantable Pacemaker Pulse-generator (Class III - Premarket Approval, product code DXY).
Submitted by Cook Pacemaker Corp. (Leechburg, US). The FDA issued a Cleared decision on October 16, 1991, 317 days after receiving the submission on December 3, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3610.
| 510(k) Number | K905403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1990 |
| Decision Date | October 16, 1991 |
| Days to Decision | 317 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXY — Implantable Pacemaker Pulse-generator |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3610 |