510(k) K192415
K192415 is an FDA 510(k) premarket notification submitted by Verily Life Sciences, LLC for the device "Study Watch with Irregular Pulse Monitor". The FDA issued a decision of Substantially Equivalent on January 17, 2020. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. Verily Life Sciences, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2020
- Date Received
- September 4, 2019
- 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