FDA.reportPublic FDA data

HearLab

Primary DI
B191HEARLABACA0
Brand
HearLab
Company
FRYE ELECTRONICS, INC.
Model
ACA
Published
2017-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWJStimulator, Auditory, Evoked Response

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B191HEARLABACA0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential graphic recording systemAn assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5036200722sales@frye.com

Regulatory Flags#

DUNS number
058131475
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
FONIX8000Fonix80002016-08-22
FONIXFP35FonixFP352016-08-22
B191FONIXCOLT0FonixColt2017-02-11

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Primary DI, Brand, Company table
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08056446901090NExT Station AdvancedEB NEURO SPAGWJ2025-05-19
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08056446900215NeMus PC PERIPHERALEB NEURO SPAGWJ2019-05-24
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08056446900239NeMus 1EB NEURO SPAGWJ2019-05-24