The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Zio Ecg Utilization Software (zeus) System.
| Device ID | K202527 |
| 510k Number | K202527 |
| Device Name: | Zio ECG Utilization Software (ZEUS) System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | iRhythm Technologies, Inc. 699 8th Street San Francisco, CA 94103 |
| Contact | Gabrielle Logan |
| Correspondent | Rey Jacinto iRhythm Technologies, Inc. 699 8th Street San Francisco, CA 94103 |
| Product Code | DQK |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DXH |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-01 |
| Decision Date | 2021-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850043907046 | K202527 | 000 |