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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 K121696
Device Name WIRELESS THERMOMETER
Applicant
Raling Medical Company
# 11, Huatong Rd.
Beijing,  CN 102200
Applicant Contact WU WEI
Correspondent
Raling Medical Company
# 11, Huatong Rd.
Beijing,  CN 102200
Correspondent Contact WU WEI
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/07/2012
Decision Date 10/11/2012
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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