Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor

Verily Life Sciences LLC · K213357 · 2022-07-19

Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor is an AI-enabled medical device from Verily Life Sciences LLC, listed by FDA (510(k), K213357) with a decision date of 2022-07-19. Review panel: Cardiovascular.

FDA submission numberK213357
Pathway510(k)
CompanyVerily Life Sciences LLC
Review panel (specialty)Cardiovascular
FDA decision date2022-07-19
DecisionSubstantially Equivalent
Product codeDXH
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Device class2
Regulation number870.2920
Review time (calendar days)280
Applicant countryUS

Official FDA database record · FDA AI-enabled device list

More devices from Verily Life Sciences LLC · All Cardiovascular AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.