FDA 510(k) Application Details - K112804

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K112804
Device Name	Oximeter
Applicant	GUANGDONG BIOLIGHT MEDITECH CO., LTD. P.O. BOX 237-023 SHANGHAI 200237 CN Other 510(k) Applications for this Company
Contact	Diana Hong 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	09/27/2011
Decision Date	01/27/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review