K872246 is an FDA 510(k) clearance for the MODIFIED MODEL 9431 TELETRACE TRANSMITTER. This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on July 21, 1987, 40 days after receiving the submission on June 11, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K872246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 1987 |
| Decision Date | July 21, 1987 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSH — Recorder, Magnetic Tape, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |