Scan Monitor

Electrocardiograph

Withings SA

The following data is part of a premarket notification filed by Withings Sa with the FDA for Scan Monitor.

Pre-market Notification Details

Device IDK201456
510k NumberK201456
Device Name:Scan Monitor
ClassificationElectrocardiograph
Applicant Withings SA 2 Rue Maurice Hartmann Issy-les-moulineaux,  FR 92130
ContactDebreuil Xavier
CorrespondentDebreuil Xavier
Withings SA 2 Rue Maurice Hartmann Issy-les-moulineaux,  FR 92130
Product CodeDPS  
Subsequent Product CodeDQA
Subsequent Product CodeDXH
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-01
Decision Date2021-10-05

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