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FDA 510(k) Application Details - K010383
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K010383
Device Name
Thermometer, Electronic, Clinical
Applicant
TENGHI CO. LTD
# 5, ALLEY 5, LANE CHENG HSING
CHUNG CHING RD. PEI TUN DIST.
TAICHUNG TW
Other 510(k) Applications for this Company
Contact
TONY C S. CHANG
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
02/08/2001
Decision Date
04/18/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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