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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 K954523
Device Name THERMOSCAN INSTANT THERMOMETER MODEL IR-6000
Applicant
Thermoscan, Inc.
10421 Pacific Center Ct.
San Diego,  CA  92121
Applicant Contact BARBARA STEVENS
Correspondent
Thermoscan, Inc.
10421 Pacific Center Ct.
San Diego,  CA  92121
Correspondent Contact BARBARA STEVENS
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/29/1995
Decision Date 12/10/1996
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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