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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 K861623
Device Name MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER
Applicant
Luxtron
1060 Terra Bella Ave.
Mountain View,  CA  94043
Applicant Contact STANLEY O HEINEMANN
Correspondent
Luxtron
1060 Terra Bella Ave.
Mountain View,  CA  94043
Correspondent Contact STANLEY O HEINEMANN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/29/1986
Decision Date 08/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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