FDA 510(k) Application Details - K181352

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K181352
Device Name	Oximeter
Applicant	Spry Health, Inc. 235 Alma Street Palo Alto, CA 94301 US Other 510(k) Applications for this Company
Contact	Elad Ferber Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2018
Decision Date	03/29/2019
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