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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 K101387
Device Name DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN
Applicant
Fudakang Industries Co., Ltd.
Rm.2706 Block A, Zhongfang
Jinyuan Bldg, Xinwen Rd.
Shenzhen, Guangdong,  CN 518034
Applicant Contact STEPHEN LING
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/18/2010
Decision Date 08/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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