INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE— 510(k) K133013

Name: FDA 510(k) clearance K133013
Creator: U.S. Food and Drug Administration
Published: 2014-01-24

Substantially Equivalent

Inventis S.R.L.

FDA 510(k) clearance K133013 for INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE, Substantially Equivalent on 2014-01-24. Applicant: Inventis S.R.L.. Device class: 2.

Clearance details

Applicant: Inventis S.R.L.
Product code: Code ETY
Device class: Class 2
Regulation: 21 CFR 874.1090
Advisory panel: Ear, Nose, Throat
Date received: 2013-09-25
Decision date: 2014-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Padova, IT

Download summary PDF View on FDA.gov ↗

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