The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Zio Patch.
| Device ID | K113862 |
| 510k Number | K113862 |
| Device Name: | ZIO PATCH |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | IRHYTHM TECHNOLOGIES, INC. 650 TOWNSEND STREET SUITE 380 San Francisco, CA 94103 |
| Contact | Michael Righter |
| Correspondent | Michael Righter IRHYTHM TECHNOLOGIES, INC. 650 TOWNSEND STREET SUITE 380 San Francisco, CA 94103 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-30 |
| Decision Date | 2012-02-06 |