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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 K101244
Device Name SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE
Applicant
Truer Medical, Inc.
1050 N Batavia St.
Orange,  CA  92867
Applicant Contact TIM TRUITT
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/04/2010
Decision Date 11/18/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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