FDA.reportPublic FDA data

Maico

Primary DI
04260176120834
Brand
Maico
Company
MAICO Diagnostics GmbH
Model
easyTymp
Published
2020-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ETYTester, Auditory Impedance

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETYTester, Auditory ImpedanceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260176120834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260176120834042601761208344260176120834

GMDN Terms#

Term, Definition table
TermDefinition
Impedance audiometerAn electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic membrane mobility due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor follow up treatment for inflammation of the middle ear.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344863550
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260176120148MaicoERO SCAN2020-04-17
04260176128304BensonCCS-200 Spirometer2021-02-15
04260176120902MaicoMA 422020-04-17
04260176128311BensonNEXT Audiometer2021-02-15
04260176120704MaicoMA 412020-04-17
04260176127444MaicoMA 422022-06-15
04260176129431MaicoeasyTone2022-06-15
04260176127628BensonCCA-100 Mini Audiometer2021-02-15
04260176127635BensonCCF-200 Fit Test2021-02-15
04260176127659BensonCCA-200 Mini Audiometer2021-02-15
04260176127666BensonCCA-200 Mini 2021-02-15
04260176127673BensonCCA-200 Mini Audiometer2021-02-15
04260176127697BensonCCA-100 Mini Audiometer2021-02-15
04260176127703BensonCCA-100 Mini Audiometer2021-02-15
04260176127734BensonCCF-200 Fit Tester2021-02-15
04260176127741BensonCCF-200 Fit Tester2021-02-15
04260176127369TREMETRICSRA3602020-07-08
04260176120377MaicoMA 252020-04-17
04260176120858MaicoMA 12020-04-17
04260176120865MaicoMA 272020-04-17

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