FDA 510(k) Application Details - K192952

Device Classification Name	System,Network And Communication,Physiological Monitors   More FDA Info for this Device
510(K) Number	K192952
Device Name	System,Network And Communication,Physiological Monitors
Applicant	Spire, Inc. d/b/a Spire Health 2030 Harrison St San Francisco, CA 94110 US Other 510(k) Applications for this Company
Contact	Joanne Hollenbach 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	10/21/2019
Decision Date	06/05/2020
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