510(k) K213357
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor by
Verily Life Sciences, LLC
— Product Code DXH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2022
- Date Received
- October 12, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type