K090363 is an FDA 510(k) clearance for the ZIO PATCH, MODEL Z100. 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 May 8, 2009, 84 days after receiving the submission on February 13, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K090363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2009 |
| Decision Date | May 08, 2009 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| 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 |