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FDA 510(k) Application Details - K150167
Device Classification Name
Vaporizer, Anesthesia, Non-Heated
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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
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Contact
TANG HO
Other 510(k) Applications for this Contact
Regulation Number
868.5880
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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
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