FDA 510(k) Application Details - K082641

Device Classification Name Oximeter

  More FDA Info for this Device
510(K) Number K082641
Device Name Oximeter
Applicant CONTEC MEDICAL SYSTEM CO., LTD.
SUITE 8D , ZHONGXIN ZHONGSHAN
MANSION, NO. 19, LANE 999,
ZHONG SHAN, SHANGHAI 20030 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 09/11/2008
Decision Date 11/10/2008
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



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