FDA 510(k) Application Details - K082487

Device Classification Name Oximeter

  More FDA Info for this Device
510(K) Number K082487
Device Name Oximeter
Applicant BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
ROOM 1127-1128 BUILDING B
BAILANGYUAN FUXING RD. #A36
BEIJING 100039 CN
Other 510(k) Applications for this Company
Contact LEI CHEN
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 08/28/2008
Decision Date 03/04/2009
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact