FDA.reportPublic FDA data

EER Stimulator and Amplifier

Primary DI
00855730007368
Brand
EER Stimulator and Amplifier
Company
DIAGNOSYS LLC
Model
D366
Device description
The EER is an electrical stimulator component that can only be used as part of the D310 & D315.
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWEStimulator, Photic, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K863956000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K863956000MACULOSCOPE(TM)Doran Instruments, Inc.1986-11-13GWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855730007368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855730007368008557300073688557300073680855730007368

GMDN Terms#

Term, Definition table
TermDefinition
ElectroretinographAn ophthalmic device used to record the changes in electric potential on or near the surface of the cornea to a reference distal point on the body, following stimulation of the retina by light, i.e., flashes of white light. The electroretinograph (ERG) recorder is used with a primary electrode [typically gold (Au), platinum (Pt) or silver (Ag)] and a reference electrode located almost anywhere on the body, e.g., cheek or ear lobe, and an amplifier that boosts the bioelectrical potential. Some are compatible with a personal computer (PC) for waveform storage and analysis. It is used in the diagnosis of retinal degeneration, night blindness, and circulatory disturbances of the retina.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
131488467
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855730007429DTL 2D141D1412024-11-11
00855730007290EspionD3102021-04-26
00855730007306EspionD3152021-04-26
00850594007011DTLD141D1412016-08-29
10855730007426DTL 2D141D1412024-11-11
00850594007004StandaloneD1752023-06-01
00855730007344ColorDome Desktop Ganzfeld StimulatorD1252022-12-12
00855730007351Envoy Mini-OLEDD3522022-12-12
00855730007375ColorFlash Handheld StimulatorD3822022-12-12
00855730007382LCD Benchtop Assembly w/ Monitor & Fixation CameraD3592022-12-12
00855730007399ColorBurst Handheld StimulatorD2132022-12-12
00855730007313EspionD3412021-04-26
00855730007320Gold LensD101D1012021-04-26
00855730007337Gold LensD102D1022021-04-26
00855730007276EspionD3102021-04-13
00855730007283EspionD3102021-04-13
00855730007269EspionD3102021-04-08
00855730007252EspionD3102020-12-02
00855730007245EspionD3152020-07-28
00855730007238EspionD3152020-04-16

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Primary DI, Brand, Company table
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08056446901106NExT-DOCKINGEB NEURO SPAGWE2025-05-22
08056446901113NExT-PADEB NEURO SPAGWE2025-05-22
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08056446901168NExT-AMPEB NEURO SPAGWE2025-05-22
08056446901199NExT-ASEB NEURO SPAGWE2025-05-22
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