KardiaMobile, KardiaStation

Transmitters And Receivers, Electrocardiograph, Telephone

AliveCor, Inc.

The following data is part of a premarket notification filed by Alivecor, Inc. with the FDA for Kardiamobile, Kardiastation.

Pre-market Notification Details

Device IDK191406
510k NumberK191406
Device Name:KardiaMobile, KardiaStation
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View,  CA  94041
ContactSaket Bhatt
CorrespondentSaket Bhatt
AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View,  CA  94041
Product CodeDXH  
Subsequent Product CodeDPS
Subsequent Product CodeQDA
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-28
Decision Date2020-01-24

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