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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 K070878
Device Name DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300
Applicant
Rg Medical Diagnostics
21130 Bridge St.
Southfield,  MI  48034
Applicant Contact RONALD G LE TOURNEAU
Correspondent
Rg Medical Diagnostics
21130 Bridge St.
Southfield,  MI  48034
Correspondent Contact RONALD G LE TOURNEAU
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/29/2007
Decision Date 06/05/2007
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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