ESOTEST MULTI Esophageal Temperature Probe And Temperature Monitoring System

Thermometer, Electronic, Clinical

Fiab SpA

The following data is part of a premarket notification filed by Fiab Spa with the FDA for Esotest Multi Esophageal Temperature Probe And Temperature Monitoring System.

Pre-market Notification Details

Device IDK192210
510k NumberK192210
Device Name:ESOTEST MULTI Esophageal Temperature Probe And Temperature Monitoring System
ClassificationThermometer, Electronic, Clinical
Applicant Fiab SpA Via Costoli, 4 Vicchio,  IT 50039
ContactFrancesco Batistini
CorrespondentFrancesco Batistini
Fiab SpA Via Costoli, 4 Vicchio,  IT 50039
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-14
Decision Date2019-10-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18054953343881 K192210 000
18058480753991 K192210 000
08058480754021 K192210 000
08058480754618 K192210 000
08058480754700 K192210 000
08054953344003 K192210 000
08054953344010 K192210 000
08054953346335 K192210 000
18054953343874 K192210 000
18058480753984 K192210 000

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