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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thermometer, electronic, clinical
510(k) Number K192210
Device Name ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
Applicant
Fiab SpA
Via Costoli, 4
Vicchio,  IT 50039
Applicant Contact Francesco Batistini
Correspondent
Fiab SpA
Via Costoli, 4
Vicchio,  IT 50039
Correspondent Contact Francesco Batistini
Regulation Number880.2910
Classification Product Code
FLL  
Subsequent Product Code
IKD  
Date Received08/14/2019
Decision Date 10/10/2019
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
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