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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 K121696
Model WTM-BT30-I
Device Name WIRELESS THERMOMETER
Original Applicant
RALING MEDICAL COMPANY
no. 11, huatong rd
beijing,  CH 102200
Original Contact wu wei
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/07/2012
Decision Date 10/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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