The following data is part of a premarket notification filed by Irhythm Technologies, Inc. with the FDA for Zeus (zio Ecg Utilization Service) System.
| Device ID | K142681 |
| 510k Number | K142681 |
| Device Name: | ZEUS (ZIO ECG Utilization Service) System |
| Classification | Computer, Diagnostic, Programmable |
| 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 | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-19 |
| Decision Date | 2014-11-21 |
| Summary: | summary |