K001634 is an FDA 510(k) clearance for the CARDIOSENTRY EVENT MONITOR, MODEL 8470-01. This device is classified as a Transmitters And Receivers, Electrocardiograph, Telephone (Class II - Special Controls, product code DXH).
Submitted by Tz Medical, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on December 21, 2000, 209 days after receiving the submission on May 26, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2920.
| 510(k) Number | K001634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2000 |
| Decision Date | December 21, 2000 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXH — Transmitters And Receivers, Electrocardiograph, Telephone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2920 |