FDA.reportPublic FDA data

EYE-SYNC

Primary DI
00868096000300
Brand
EYE-SYNC
Company
NEUROSYNC INC.
Model
X02
Published
2017-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWNNystagmograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWNNystagmographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152915000EYE-SYNCSyncthink, Inc.2016-01-29GWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868096000300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868096000300008680960003008680960003000868096000300

GMDN Terms#

Term, Definition table
TermDefinition
Vision/eye movement analysis systemAn electronic unit or device assembly intended to measure, record, and display a range of parameters associated with vision electrophysiology [e.g., electroretinogram (ERG), visual evoked potential (VEP), electrooculogram (EOG)], and/or psychophysical vision (e.g., visual acuity/fields, refractive error, contrast sensitivity, colour perception), and/or eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation/screening. Features may include visual stimuli (e.g., patterns of light/images) and/or devices for sensing/tracking (e.g., bioelectric amplifiers, video or infrared cameras). It is intended to be used by a healthcare professional in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
617-221-3813support@syncthink.com

Regulatory Flags#

DUNS number
966659307
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013612900EYE-SYNCX032025-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B516327270Instrumentation Difra SAInstrumentation Difra SAGWN2026-03-09
05711117244991InteracousticsInteracoustics A/SGWN2025-08-14
05711117245004InteracousticsInteracoustics A/SGWN2025-08-14
05711117245028InteracousticsInteracoustics A/SGWN2025-08-14
00860013612900EYE-SYNCNEUROSYNC INC.GWN2025-03-12
B516325950Instrumentation Difra SAInstrumentation Difra SAGWN2025-03-12
B516326290Instrumentation Difra SAInstrumentation Difra SAGWN2025-03-12
B516326380Instrumentation Difra SAInstrumentation Difra SAGWN2025-03-12
057133150107361091, ICS Dizcovery SystemNatus Medical Denmark ApSGWN2025-02-21
057133150108111091, ICS Dizcovery ShadeShift Panels Natus Medical Denmark ApSGWN2025-02-21
057133150108281091, ICS Dizcovery LCD PanelsNatus Medical Denmark ApSGWN2025-02-21
057133150108801091, ICS Dizcovery Universal Face Cushion (qty 40)Natus Medical Denmark ApSGWN2025-02-21
08054187380815Synapsys VHITINVENTIS SRLGWN2025-01-08
08054187380822Synapsys VHITINVENTIS SRLGWN2025-01-08
B366VN1061R00VNG 3DEclerisGWN2024-12-17
05713315007132GN Otometrics A/SNatus Medical Denmark ApSGWN2024-12-04
08054187380983VNGINVENTIS SRLGWN2024-10-01
08054187380990VNGINVENTIS SRLGWN2024-10-01
08054187381003VNGINVENTIS SRLGWN2024-10-01
08054187381010VNGINVENTIS SRLGWN2024-10-01
08054187381027VNGINVENTIS SRLGWN2024-10-01
08054187381034VNGINVENTIS SRLGWN2024-10-01
08054187381041VNGINVENTIS SRLGWN2024-10-01
08054187381058VNGINVENTIS SRLGWN2024-10-01
08054187381065VNGINVENTIS SRLGWN2024-10-01
B516308640Instrumentation Difra SAInstrumentation Difra SAGWN2024-08-19
B366VN1061VNG 3DEclerisGWN2024-05-20
20763000467344NAMEDTRONIC PS MEDICAL, INC.GWN2024-03-01
00763000467340NAMEDTRONIC PS MEDICAL, INC.GWN2024-03-01
20763000467351NAMEDTRONIC PS MEDICAL, INC.GWN2024-02-26