Fitbit ECG App

Electrocardiograph Software For Over-the-counter Use

Fitbit, Inc.

The following data is part of a premarket notification filed by Fitbit, Inc. with the FDA for Fitbit Ecg App.

Pre-market Notification Details

Device IDK200948
510k NumberK200948
Device Name:Fitbit ECG App
ClassificationElectrocardiograph Software For Over-the-counter Use
Applicant Fitbit, Inc. 199 Fremont Street San Francisco,  CA  94105
ContactShruti Rajagopalan
CorrespondentShruti Rajagopalan
Fitbit, Inc. 199 Fremont Street San Francisco,  CA  94105
Product CodeQDA  
CFR Regulation Number870.2345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-08
Decision Date2020-09-11

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