KardiaMobile 6L

Electrocardiograph

AliveCor, Inc.

The following data is part of a premarket notification filed by Alivecor, Inc. with the FDA for Kardiamobile 6l.

Pre-market Notification Details

Device IDK210753
510k NumberK210753
Device Name:KardiaMobile 6L
ClassificationElectrocardiograph
Applicant AliveCor, Inc. 444 Castro Street, Suite 600 Mountain View,  CA  94041
ContactSaket Bhatt
CorrespondentPrabhu Raghavan
MDQR, LLC 444 Castro Street, Suite 600 Mountain View,  CA  94041
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-15
Decision Date2021-06-30

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