FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Maico Diagnostics model MI 44 Tympanometer is intended for use by trained operators in hospitals, ENT clinics and audiologist offices for the detection of possible otologic disorders associated with the functioning of the middle ear. This is accomplished by measuring the acoustic impedance of the ear canal under various conditions.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the Maico Diagnostics MI 44 Tympanometer, indicating that it has been found substantially equivalent to a predicate device. It does not contain a detailed description of acceptance criteria or a study proving that the device meets those criteria, as typically seen in a clinical trial report or a performance study summary.

Therefore,Based on the provided text, I cannot answer the request as the document does not contain the information required to describe the acceptance criteria and the study that proves the device meets them. The document is primarily a 510(k) clearance letter confirming substantial equivalence to a predicate device. It does not include performance data, study design details, or acceptance criteria in the format requested.

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K Number

K003913

Device Name

HINT AUDIOMETER, OR HINT

Manufacturer

MAICO-DIAGNOSTICS

Date Cleared

2001-03-16

(87 days)

Product Code