FDA 510(k) Application Details - K212112

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K212112
Device Name	Electrocardiograph
Applicant	Cardiologs Technologies 136 Rue Saint Denis Paris 75002 FR Other 510(k) Applications for this Company
Contact	Arezou Azar 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	07/06/2021
Decision Date	11/18/2021
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