FDA 510(k) Application Details - K180380

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K180380
Device Name	Oximeter
Applicant	Edan Instruments, Inc. #15 Jinhui Road,Jinsha Community Kengzi Sub-District Pingshan District Shenzhen 518122 CN Other 510(k) Applications for this Company
Contact	Alice Yang 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	02/12/2018
Decision Date	12/21/2018
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