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FDA 510(k) Application Details - K010238
Device Classification Name
Thermometer, Electronic, Clinical
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510(K) Number
K010238
Device Name
Thermometer, Electronic, Clinical
Applicant
ACTHERM, INC.
10TH F. #43 KUAN-MIN 6 ROAD
JUBEI, HSINCHU 302 TW
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Contact
RICHARD HSIEH
Other 510(k) Applications for this Contact
Regulation Number
880.2910
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Classification Product Code
FLL
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More FDA Info for this Product Code
Date Received
01/25/2001
Decision Date
02/06/2001
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
Y
Expedited Review
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