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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 K844624
Device Name BASIS DIGITAL THERMOMETER MODEL BTM-1
Applicant
Terayco Intl., Ltd.
300 E. Mineral Ave.
Suite 6
Littleton,  CO  80122
Applicant Contact JAMES H GRAY
Correspondent
Terayco Intl., Ltd.
300 E. Mineral Ave.
Suite 6
Littleton,  CO  80122
Correspondent Contact JAMES H GRAY
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/27/1984
Decision Date 03/21/1985
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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