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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 K090361
Device Name REMOTE INFRARED THERMOMETER, MODEL RC002
Applicant
Rycom Electron Technology Limited
Suite 8d, # 19, Ln. 999
Zhongshan # 2 Rd. (S)
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Rycom Electron Technology Limited
Suite 8d, # 19, Ln. 999
Zhongshan # 2 Rd. (S)
Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/12/2009
Decision Date 10/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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