The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Zio At Ecg Monitoring System, Zeus System.
| Device ID | K181502 |
| 510k Number | K181502 |
| Device Name: | Zio AT ECG Monitoring System, ZEUS System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | iRhythm Technologies, Inc. 650 Townsend Street, Suite 500 San Francisco, CA 94103 |
| Contact | Rich Laguna |
| Correspondent | Rich Laguna iRhythm Technologies, Inc. 650 Townsend Street, Suite 500 San Francisco, CA 94103 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-07 |
| Decision Date | 2018-08-29 |
| Summary: | summary |