Cardiologs Holter Platform

Electrocardiograph

Cardiologs Technologies

The following data is part of a premarket notification filed by Cardiologs Technologies with the FDA for Cardiologs Holter Platform.

Pre-market Notification Details

Device IDK212112
510k NumberK212112
Device Name:Cardiologs Holter Platform
ClassificationElectrocardiograph
Applicant Cardiologs Technologies 136 Rue Saint Denis Paris,  FR 75002
ContactArezou Azar
CorrespondentArezou Azar
Cardiologs Technologies 136 Rue Saint Denis Paris,  FR 75002
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-06
Decision Date2021-11-18

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