FDA 510(k) Application Details - K172492

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K172492
Device Name	Oximeter
Applicant	Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg, OH 44087 US Other 510(k) Applications for this Company
Contact	Doug Thistlethwaite 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	08/17/2017
Decision Date	08/17/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review