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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 K923189
Device Name LUXTRON MODEL 3100/3101/3102 MULTICHANNEL
Applicant
Luxtron
2775 Northwestern Pkwy.
Santa Clara,  CA  95051
Applicant Contact PETER L COLCORD
Correspondent
Luxtron
2775 Northwestern Pkwy.
Santa Clara,  CA  95051
Correspondent Contact PETER L COLCORD
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/30/1992
Decision Date 03/28/1994
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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