FDA.reportPublic FDA data

Seer Home

Primary DI
09355751001242
Brand
Seer Home
Company
SEER MEDICAL HOLDINGS LIMITED
Model
Seer Cloud
Device description
Seer Cloud
Published
2024-06-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212788000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212788000Seer HomeSeer Medical Pty, Ltd.2022-06-16GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09355751001242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09355751001242093557510012429355751001242

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographAn electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
744473197
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09355751001174Seer HomeSM-01-80012024-06-27
09355751001181Seer HomeSM-03-8001-INT2024-06-27
09355751001228Seer HomeMonitoring Portal2024-06-27
09355751001235Seer HomeSeer App: Epilepsy Management2024-06-27
09355751001037Seer HomeSM-03-8001-INT2023-09-14
09355751001136Seer HomeMonitoring Portal2023-09-05
09355751001020Seer HomeSM-01-80012023-09-04
09355751001051Seer HomeSeer App: Epilepsy Management2023-09-04
09355751001211Seer HomeSM-07-80012024-06-27
09355751001259Seer HomeSM-01-90082024-06-27
09355751001266Seer HomeSM-01-90052024-06-27
09355751001105Seer HomeSM-01-90082023-09-14
09355751001099Seer HomeSM-01-9003-US2023-09-05
09355751001112Seer HomeSM-01-90052023-09-05
09355751001129Seer HomeSM-07-80012023-06-21
19355751001218Seer HomeSM-07-80012024-06-27
09355751001273Seer HomeSM-01-90082024-06-27
09355751001044Seer HomeSeer Cloud2023-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016073401Evoke EEG SystemFirefly Neuroscience, Inc.GWQ2026-07-07
00860016073418Evoke EEG System AmplifierFirefly Neuroscience, Inc.GWQ2026-07-07
B592SW100WAVi Scan SoftwareWAVI CO.GWQ2026-03-25
B592WD100WAVi Electrical Processing UnitWAVI CO.GWQ2026-03-25
B592WK200WAVi Scan KitWAVI CO.GWQ2026-03-25
B675PDDU0Zeto ONE Display UnitZETO, INC.GWQ2025-11-19
08690020003062BrainView NeuralScanMedeia, Inc.GWQ2025-02-05
08056446900673Neurotravel LIGHTEB NEURO SPAGWQ2024-12-04
08056446900680Neurotravel LIGHT Base UnitEB NEURO SPAGWQ2024-12-04
08056446900895BE PLUS PRO LIGHTEB NEURO SPAGWQ2024-12-04
08056446900901BE PLUS PRO STANDARDEB NEURO SPAGWQ2024-12-04
08056446900918BE PLUS PRO FULLEB NEURO SPAGWQ2024-12-04
08056446900925BE PLUS PRO ADVANCEDEB NEURO SPAGWQ2024-12-04
08056446900932BE PLUS PRO Battery PackEB NEURO SPAGWQ2024-12-04
08056446901311BE PLUS PRO [LIGHT] EB NEURO SPAGWQ2024-12-04
08056446901328BE PLUS PRO [STANDARD]EB NEURO SPAGWQ2024-12-04
08056446901335BE PLUS PRO [FULL]EB NEURO SPAGWQ2024-12-04
08056446901342BE PLUS PRO [ADVANCED]EB NEURO SPAGWQ2024-12-04
B675ONEECG1Zeto ONE ECG Cable Extension SetZETO, INC.GWQ2024-06-11
18437017440601Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440632Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440663Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
18437017440687Enobio DxNEUROELECTRICS BARCELONA SLGWQ2023-09-14
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyGWQ2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyGWQ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyGWQ2023-04-19
00195278524089NAGE Healthcare Finland OyGWQ2023-04-19
09342451002112SiestaCompumedics Usa, Inc.GWQ2020-12-16
09342451001788SiestaCompumedics Usa, Inc.GWQ2020-12-15
08056446900642Galileo NT Line SoftwareEB NEURO SPAGWQ2020-05-25