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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 K841105
Device Name MULTICHANNEL 2000 FLUOROPTIC THERMOMET
Applicant
Luxtron
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Luxtron
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/14/1984
Decision Date 07/03/1984
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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