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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 K121427
Model T2252-AS, THP-AS, TMQ-AS, TSW-AS, TSM-15AS, TSL-AS, TMR-AS, T2252-AG, THP-AG, TMQ-AG, TSW-AG, TSM-15AG, TSL-AG, TMR-AG
Device Name UNIMED TEMPERATURE PROBE
Original Applicant
UNIMED MEDICAL SUPPLIES INC.
no.37, yanshan road, shekou
shenzhen, guangdong,  CH 518067
Original Contact xinmei tan
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/14/2012
Decision Date 05/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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