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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 K853713
Device Name FIRST TEMP
Applicant
Intelligent Medical Systems
2233 Faraday Ave. Suite K
Carlsbad,  CA  92008
Applicant Contact DAVID B PHILLIPS
Correspondent
Intelligent Medical Systems
2233 Faraday Ave. Suite K
Carlsbad,  CA  92008
Correspondent Contact DAVID B PHILLIPS
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/05/1985
Decision Date 11/01/1985
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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