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FDA 510(k) Application Details - K041694
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K041694
Device Name
Thermometer, Electronic, Clinical
Applicant
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,
BUILDING 2, BAIMIAO INDU. PARK
ECONOMIC DEVELOP. ZONE WUCHANG
HANGZHOU, ZHEJIANG 310023 CN
Other 510(k) Applications for this Company
Contact
JI BO
Other 510(k) Applications for this Contact
Regulation Number
880.2910
More FDA Info for this Regulation Number
Classification Product Code
FLL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/22/2004
Decision Date
09/13/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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