K880738 is an FDA 510(k) clearance for the MODEL 2331T PATIENT PROGRAMMER. This device is classified as a Programmer, Pacemaker (Class III - Premarket Approval, product code KRG).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on November 17, 1988, 267 days after receiving the submission on February 24, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3700.
| 510(k) Number | K880738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 1988 |
| Decision Date | November 17, 1988 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KRG — Programmer, Pacemaker |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3700 |