The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Zio Monitor.
| Device ID | K202359 |
| 510k Number | K202359 |
| Device Name: | Zio Monitor |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | iRhythm Technologies, Inc. 699 8th Street San Francisco, CA 94103 |
| Contact | Rich Laguna |
| Correspondent | Rey Jacinto iRhythm Technologies, Inc. 699 8th Street 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 | 2020-08-19 |
| Decision Date | 2021-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869770000241 | K202359 | 000 |