Device Classification Name |
transmitters and receivers, electrocardiograph, telephone
|
510(k) Number |
K173248 |
Device Name |
CARDIOSKIN |
Applicant |
Bioserenity SAS |
47 boulevard de l'Hopital |
Paris,
FR
75013
|
|
Applicant Contact |
Quang Tran |
Correspondent |
Voisin Consulting Inc. Life Sciences |
222 Third Street |
Suite 3121 |
Cambridge,
MA
02142
|
|
Correspondent Contact |
Esin Yesilalan |
Regulation Number | 870.2920
|
Classification Product Code |
|
Date Received | 10/10/2017 |
Decision Date | 08/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|