FDA 510(k) Application Details - K193043

Device Classification Name	System,Network And Communication,Physiological Monitors   More FDA Info for this Device
510(K) Number	K193043
Device Name	System,Network And Communication,Physiological Monitors
Applicant	Critical Alert 4901 Belfort Road, Suite 130 Jacksonville, FL 32256 US Other 510(k) Applications for this Company
Contact	John Elms 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	10/31/2019
Decision Date	05/11/2020
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