FDA 510(k) Application Details - K201456

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K201456
Device Name	Electrocardiograph
Applicant	Withings SA 2 rue Maurice Hartmann Issy-Les-Moulineaux 92130 FR Other 510(k) Applications for this Company
Contact	Debreuil Xavier Other 510(k) Applications for this Contact
Regulation Number	870.2340   More FDA Info for this Regulation Number
Classification Product Code	DPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2020
Decision Date	10/05/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review