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 | K091075 |
| 510k Number | K091075 |
| 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 | Michael Righter |
| Correspondent | Michael Righter 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-14 |
| Decision Date | 2009-07-21 |
| Summary: | summary |