FDA 510(k) Application Details - K212163

Device Classification Name	Electrocardiograph   More FDA Info for this Device
510(K) Number	K212163
Device Name	Electrocardiograph
Applicant	Coala Life AB Kalsangsgrand 10B Uppsala 75319 SE Other 510(k) Applications for this Company
Contact	Dan Pitulia 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	07/12/2021
Decision Date	04/14/2022
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