FDA 510(k) Application Details - K150167

Device Classification Name Vaporizer, Anesthesia, Non-Heated

  More FDA Info for this Device
510(K) Number K150167
Device Name Vaporizer, Anesthesia, Non-Heated
Applicant SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
MINDRAY BUILDING, KEJI 12TH RD
SOUTH, HI-TECH INDUSTRIAL PARK
NANSHAN,SHENZHEN, P.R. CHINA 518057 CN
Other 510(k) Applications for this Company
Contact TANG HO
Other 510(k) Applications for this Contact
Regulation Number 868.5880

  More FDA Info for this Regulation Number
Classification Product Code CAD
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 01/26/2015
Decision Date 06/30/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
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