FDA.reportPublic FDA data

Maico

Primary DI
08584270041663
Brand
Maico
Company
Diagnostic Group LLC
Model
easyTymp
Published
2016-09-24
Public version status
Update
Distribution status
Not 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
08584270041663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08584270041663085842700416638584270041663

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.

Regulatory Flags#

DUNS number
175799717
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810046707180Grason-StadlerGSI AudioHub2026-04-06
08584270045074MaicoEroScan2018-07-24
00810046700006Grason-StadlerGSI 182016-11-10
00810046700075Grason-StadlerGSI Pello2016-11-28
00810046700129Grason-StadlerGSI Novus2017-10-24
00810046700235Grason-StadlerGSI AMTAS Flex2017-07-26
00810046700266Grason-StadlerGSI AMTAS Flex2017-11-29
00810046700273Grason-StadlerGSI AMTAS Flex2017-11-29
00810046700488Grason-StadlerGSI AudioStar Pro2018-10-22
08584270041069Grason-StadlerGSI AudioStar Pro2016-11-10
08584270041106TremetricsRA8002016-11-10
08584270041151MaicoMA 42 2016-11-10
08584270041168MaicoMA 522016-09-24
08584270041267MaicoMA 272016-11-10
08584270041298MaicoDigital Pilot Test 2016-11-10
08584270041311TremetricsRA3002016-11-10
08584270041328TremetricsHT Wizard Ultra2016-11-10
08584270041526MaicoMA 12016-11-10
08584270041533MaicoMA 252016-11-10
08584270041557MaicoMA 412016-09-24

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