FDA.reportPublic FDA data

Espion

Primary DI
00850594007059
Brand
Espion
Company
DIAGNOSYS LLC
Model
D310
Device description
Profile System; with ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-R-1-NNNN-2-N
Published
2016-08-31
Public version status
Update
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
00850594007059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850594007059008505940070598505940070590850594007059

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131488467
Device count
1
DM exempt
true
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
00855730007368EER Stimulator and AmplifierD3662022-12-12
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

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