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Found 2 results

510(k) Data Aggregation

K Number

Device Name

MODEL MI 44 TYMPANOMETER

Manufacturer

MAICO-DIAGNOSTICS

Date Cleared

2006-06-05

(66 days)

Product Code

EWO

Regulation Number

874.1050

Why did this record match?

Applicant Name (Manufacturer) :

MAICO-DIAGNOSTICS

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

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

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K Number

Device Name

HINT AUDIOMETER, OR HINT

Manufacturer

MAICO-DIAGNOSTICS

Date Cleared

2001-03-16

(87 days)

Product Code

EWO

Regulation Number

874.1050

Why did this record match?

Applicant Name (Manufacturer) :

MAICO-DIAGNOSTICS

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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