FDA 510(k) Application Details - K191272

Device Classification Name	System,Network And Communication,Physiological Monitors   More FDA Info for this Device
510(K) Number	K191272
Device Name	System,Network And Communication,Physiological Monitors
Applicant	Current Health Ltd. Playfair House, 12A Broughton Street Lane Edinburgh EH1 3LY GB Other 510(k) Applications for this Company
Contact	Edwin Lindsay Other 510(k) Applications for this Contact
Regulation Number	870.2300   More FDA Info for this Regulation Number
Classification Product Code	MSX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2019
Decision Date	07/12/2019
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