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FDA 510(k) Application Details - K070028
Device Classification Name
Thermometer, Electronic, Clinical
More FDA Info for this Device
510(K) Number
K070028
Device Name
Thermometer, Electronic, Clinical
Applicant
ACTHERM, INC.
6TH F., #85 KUAN-MIN 6 RD.
JUBEI, HSINCHU 302 TW
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Contact
RICHARD HSIEH
Other 510(k) Applications for this Contact
Regulation Number
880.2910
More FDA Info for this Regulation Number
Classification Product Code
FLL
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More FDA Info for this Product Code
Date Received
01/03/2007
Decision Date
02/08/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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