The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Zio Xt Ecg Monitoring System, Zio At Ecg Monitoring System.
| Device ID | K190593 |
| 510k Number | K190593 |
| Device Name: | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | iRhythm Technologies, Inc. 650 Townsend Street, Ste 500 San Francisco, CA 94103 |
| Contact | Gabrielle Logan |
| Correspondent | Gabrielle Logan iRhythm Technologies, Inc. 650 Townsend Street, Ste 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 | 2019-03-07 |
| Decision Date | 2019-08-23 |