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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 K930680
Device Name THERMOSCAN INSTANT THERMOMETER IR-5000
Applicant
Thermoscan, Inc.
10309 Pacific Center Ct.
San Diego,  CA  92121
Applicant Contact LACYNE Y AVERY
Correspondent
Thermoscan, Inc.
10309 Pacific Center Ct.
San Diego,  CA  92121
Correspondent Contact LACYNE Y AVERY
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/10/1993
Decision Date 07/20/1994
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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