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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 K920713
Device Name FIRSTTEMP GENIUS
Applicant
Intelligent Medical Systems
6339 Paseo Del Lago
Carlsbad,  CA  92009
Applicant Contact GARY J O'HARA
Correspondent
Intelligent Medical Systems
6339 Paseo Del Lago
Carlsbad,  CA  92009
Correspondent Contact GARY J O'HARA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/18/1992
Decision Date 12/17/1992
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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