K113862 is an FDA 510(k) clearance for the ZIO PATCH. This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).
Submitted by iRhythm Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on February 6, 2012, 38 days after receiving the submission on December 30, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K113862 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2011 |
| Decision Date | February 06, 2012 |
| Days to Decision | 38 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DSH - Recorder, Magnetic Tape, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |