Study Watch With Irregular Pulse Monitor

Transmitters And Receivers, Electrocardiograph, Telephone

Verily Life Sciences LLC

The following data is part of a premarket notification filed by Verily Life Sciences Llc with the FDA for Study Watch With Irregular Pulse Monitor.

Pre-market Notification Details

Device IDK192415
510k NumberK192415
Device Name:Study Watch With Irregular Pulse Monitor
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant Verily Life Sciences LLC 269 E Grand Avenue South San Francisco,  CA  94080
ContactConnie Pascual
CorrespondentRichard M. Stewart
Verily Life Sciences LLC 269 E Grand Avenue South San Francisco,  CA  94080
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-04
Decision Date2020-01-17

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