Cleared Traditional

CARDIOSKIN

K173248 · Bioserenity Sas · Cardiovascular

Aug 2018

Decision

305d

Days

Class 2

Risk

About This 510(k) Submission

K173248 is an FDA 510(k) clearance for the CARDIOSKIN, a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by Bioserenity Sas (Paris, FR). The FDA issued a Cleared decision on August 11, 2018, 305 days after receiving the submission on October 10, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number	K173248 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 2017
Decision Date	August 11, 2018
Days to Decision	305 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF