FDA.reportPublic FDA data

Maico

Primary DI
04260176120513
Brand
Maico
Company
MAICO Diagnostics GmbH
Model
MB 11 BERAphone
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
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082035000MAICO MB 11 WITH BERAPHONE PROBEMaico Diagnostics2009-01-29GWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260176120513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260176120513042601761205134260176120513

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential audiometerAn electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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04260223147654Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147661Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147678Bone Conductor BC-2LDPATH medical GmbHGWJ2026-07-24
04260223147746Ear Coupler TRPATH medical GmbHGWJ2026-07-24
04260223147975PIEP (2x2)PATH medical GmbHGWJ2026-07-24
04260223148002Accessory box AB-LT02PATH medical GmbHGWJ2026-07-24
05713315006890Madsen AccsucreenNatus Medical Denmark ApSGWJ2026-07-08
05713315006906Madsen AccuscreenNatus Medical Denmark ApSGWJ2026-07-08
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWJ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWJ2026-07-07
00817020020723Screener CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020020990Trigger Out Cable for USB Jr DuetINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
00817020021140Diagnostic CartINTELLIGENT HEARING SYSTEMS CORP.GWJ2026-06-10
B592SW100WAVi Scan SoftwareWAVI CO.GWJ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWJ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWJ2026-03-25
08056446901106NExT-DOCKINGEB NEURO SPAGWJ2025-05-22
08056446901113NExT-PADEB NEURO SPAGWJ2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWJ2025-05-22
08056446901137NExT-HSEB NEURO SPAGWJ2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWJ2025-05-22
08056446901199NExT-ASEB NEURO SPAGWJ2025-05-22
08056446901205NExT StationEB NEURO SPAGWJ2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWJ2025-05-19
00817020021126AriaINTELLIGENT HEARING SYSTEMS CORP.GWJ2024-03-11
00627908020178EP HeadphonesVivosonic IncGWJ2023-06-08
00627908020185ECochG AdaptersVivosonic IncGWJ2023-06-08