FDA 510(k) Application Details - K092727

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K092727
Device Name	Oximeter
Applicant	EDAN INSTRUMENTS, INC. SUITE 8D, NO.19, LANE 999 ZHONGSHAN ROAD (S-2) SHANGHAI 200030 CN Other 510(k) Applications for this Company
Contact	LI FU 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	09/04/2009
Decision Date	12/03/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review