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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 K180047
Device Name ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
Applicant
Fiab Spa
Via Costoli, 4
Vicchio,  IT 50039
Applicant Contact Alberto Calabro
Correspondent
Fiab Spa
Via Costoli, 4
Vicchio,  IT 50039
Correspondent Contact Francesco Batistini
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/08/2018
Decision Date 11/08/2018
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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