iRhythm Technologies, Inc. · Class II · Cleared Jul 19, 2022
| K-number | K213409 |
| Device name | ZEUS System (Zio Watch) |
| Applicant | iRhythm Technologies, Inc. |
| Product code | DQK |
| Device class | Class II |
| Decision date | Jul 19, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov