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510(k) Data Aggregation
K Number
K133013Device Name
INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE
Manufacturer
INVENTIS SRL
Date Cleared
2014-01-24
(121 days)
Product Code
ETY
Regulation Number
874.1090Why did this record match?
Applicant Name (Manufacturer) :
INVENTIS SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Inventis Middle Ear Analyzers, Flute and Viola, are intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The Inventis Middle Ear Analyzers are intended for use on individuals six months of age or older. Flute is a tympanometer. Viola is a combination of audiometer and tympanometer, which reduces the amount of necessary equipment.
Device Description
Flute is stand-alone tympanometry / reflex diagnostic device. Viola is a stand-alone combined unit, integrating a screening middle ear analyzer and a diagnostic audiometer capable of performing air and bone conduction threshold and speech exams. Flute and Viola are available with or without the integrated thermal printer.
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