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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K020433
Device Name FT101 FOREHEAD THERMOMETER; FT101 INFRARED DIGITAL THERMOMETER
Applicant
Idt Technology Limited
P.O. Box 391117
Solon,  OH  44139
Applicant Contact JAMES J ROGERS
Correspondent
Idt Technology Limited
P.O. Box 391117
Solon,  OH  44139
Correspondent Contact JAMES J ROGERS
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/08/2002
Decision Date 07/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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