FDA 510(k) K173248, CARDIOSKIN, by Bioserenity Sas
FDA 510(k) K173248, CARDIOSKIN, by Bioserenity Sas
Device Classification Name: Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number: K173248
Device Name: CARDIOSKIN
Applicant: Bioserenity Sas
Regulation Number: 870.292
Classification Product Code: DXH
Date Received: 2017-10-10
Decision Date: 2018-08-11
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular
Total number of pages: 1,626
Fully redacted pages: 20
Content pages: 1,606
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