FLUTE

INVENTIS SRL · Model FLUTE PLUS WITH PRINTER · UDI-DI 08054187380280

PTO Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

MIDDLE EAR ANALYZER. Flute Plus is a middle ear analyzer, capable of performing: tympanometry, and acoustic reflex tests in sequence and automatically, manual tympanometry, the Eustachian tube function test for intact eardrums, the reflex decay test and the facility of conducting the acoustic reflex test in manual mode. In addition, it allows to adjuste manually the pressure setting used for reflex tests. Flute Plus with Printer has, in addition, an integrated thermal printer.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.