CARDIOSKIN

Transmitters And Receivers, Electrocardiograph, Telephone

Bioserenity SAS

The following data is part of a premarket notification filed by Bioserenity Sas with the FDA for Cardioskin.

Pre-market Notification Details

Device IDK173248
510k NumberK173248
Device Name:CARDIOSKIN
ClassificationTransmitters And Receivers, Electrocardiograph, Telephone
Applicant Bioserenity SAS 47 Boulevard De L'Hopital Paris,  FR 75013
ContactQuang Tran
CorrespondentEsin Yesilalan
Voisin Consulting Inc. Life Sciences 222 Third Street Suite 3121 Cambridge,  MA  02142
Product CodeDXH  
CFR Regulation Number870.2920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-10
Decision Date2018-08-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03615220001156 K173248 000
03615220001033 K173248 000
03615220001040 K173248 000
03615220001057 K173248 000
03615220001064 K173248 000
03615220001071 K173248 000
03615220001088 K173248 000
03615220001095 K173248 000
03615220001101 K173248 000
03615220001118 K173248 000
03615220001125 K173248 000
03615220001132 K173248 000
03615220001149 K173248 000
03615220001026 K173248 000

Trademark Results [CARDIOSKIN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CARDIOSKIN
CARDIOSKIN
79199348 5455572 Live/Registered
BIOFARMA
2016-08-04

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