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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 K935603
Device Name EXTRACORPOREAL TEMPERATURE SENSOR
Applicant
Smiths Industries Medical Systems, Inc.
2552 Mcgaw Ave.
Irvine,  CA  92714
Applicant Contact KERRY TOMIC
Correspondent
Smiths Industries Medical Systems, Inc.
2552 Mcgaw Ave.
Irvine,  CA  92714
Correspondent Contact KERRY TOMIC
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/18/1993
Decision Date 02/15/1994
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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