K102507 is an FDA 510(k) clearance for the AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Tz Medical, Inc. (Portland, US). The FDA issued a Cleared decision on June 13, 2011, 285 days after receiving the submission on September 1, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K102507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2010 |
| Decision Date | June 13, 2011 |
| Days to Decision | 285 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSI — Detector And Alarm, Arrhythmia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |