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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K141505
Device Name BASAL DIGITAL THERMOMETER
Applicant
K-JUMP HEALTH CO., LTD.
NO. 56, WU KUNG 5TH RD.,
NEW TAIPEI INDUST PARK
NEW TAIPEI,  TW 24890
Applicant Contact JM LIN
Correspondent
K-JUMP HEALTH CO., LTD.
NO. 56, WU KUNG 5TH RD.,
NEW TAIPEI INDUST PARK
NEW TAIPEI,  TW 24890
Correspondent Contact JM LIN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/06/2014
Decision Date 08/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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