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510(k) K192415

Study Watch with Irregular Pulse Monitor by Verily Life Sciences, LLC — Product Code DXH

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

Other clearances by Verily Life Sciences, LLC

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  • K213357 — Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Puls (July 19, 2022)
  • K182456 — Study Watch (January 17, 2019)

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  • K233521 — QT ECG (QTERD100) (December 6, 2023)
  • K222842 — V-Patch Cardiac Monitor (October 20, 2022)
  • K220795 — QT ECG (September 26, 2022)
  • K213357 — Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Puls (July 19, 2022)
  • K220350 — KardiaMobile 6L (May 25, 2022)