The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Zio Patch, Model Z100.
| Device ID | K090363 |
| 510k Number | K090363 |
| Device Name: | ZIO PATCH, MODEL Z100 |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | IRHYTHM TECHNOLOGIES, INC. 650 TOWNSEND STREET SUITE 380 San Francisco, CA 94103 |
| Contact | William H Righter |
| Correspondent | William H 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-13 |
| Decision Date | 2009-05-08 |