FDA 510(k) Application Details - K182040

Device Classification Name	Transmitters And Receivers, Electrocardiograph, Telephone   More FDA Info for this Device
510(K) Number	K182040
Device Name	Transmitters And Receivers, Electrocardiograph, Telephone
Applicant	Coala Life AB Riddargatan 18 Stockholm 114 51 SE Other 510(k) Applications for this Company
Contact	Philip Siberg Other 510(k) Applications for this Contact
Regulation Number	870.2920   More FDA Info for this Regulation Number
Classification Product Code	DXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2018
Decision Date	02/08/2019
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