The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Zio At Ecg Monitoring System.
| Device ID | K163512 |
| 510k Number | K163512 |
| Device Name: | Zio AT ECG Monitoring System |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | IRHYTHM TECHNOLOGIES, INC. 650 TOWNSEND STREET SUITE 380 San Francisco, CA 94103 |
| Contact | Rich Laguna |
| Correspondent | Rich Laguna IRHYTHM TECHNOLOGIES, INC. 650 TOWNSEND STREET SUITE 380 San Francisco, CA 94103 |
| Product Code | DSI |
| Subsequent Product Code | DQK |
| Subsequent Product Code | DSH |
| Subsequent Product Code | DXH |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-15 |
| Decision Date | 2017-06-02 |
| Summary: | summary |