FDA.reportPublic FDA data

Micromed

Primary DI
08033928121207
Brand
Micromed
Company
MICROMED SPA
Model
LED PHOTIC POWER
Device description
LED PHOTIC POWER is the power supply adapter included in LED PHOTIC System. LED PHOTIC System is used for the photic stimulation of the patient during the EEG recording
Published
2021-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K211974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211974000LED PHOTIC SystemMicromed S.P.A.2021-09-23GWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033928121207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033928121207080339281212078033928121207

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic flash generatorA mains electricity (AC-powered), electronic, device that is used to generate an extremely strong flash or series of flashes of bright light that are used as a photostimulation in a parent device, e.g., an electroencephalograph (EEG), an electroretinograph (ERG), or a euthyscope. This device may be known as a flash booster.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
856998166
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033928120910micromedBRAIN QUICK2018-03-21
08033928121184MicromedLED PHOTIC2021-10-25
08033928120880micromedSystemPlus EVOLUTION2018-03-21
08033928120958MicromedBRAIN QUICK SOFTWARE2018-05-21
08033928120828MicromedSD LTM STIM2018-07-02
08033928120736micromedSD LTM 32 EXPRESS2018-03-21
08033928120743micromedBRAIN SPY PLUS2018-03-21
08033928120750micromedSD LTM 64 EXPRESS2018-03-21
08033928120798micromedMORPHEUS2018-03-21
08033928120897MicromedSD LTM 64 PLUS2018-05-21
08033928120903MicromedSD LTM 32 PLUS2018-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857901006620RETeval™L K C TECHNOLOGIES, INC.GWE2025-07-01
00857901006637RETeval™L K C TECHNOLOGIES, INC.GWE2025-07-01
08056446900338NeMus 2 600EB NEURO SPAGWE2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWE2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWE2025-05-26
08056446901038GOGGLES STIMULATOR IIEB NEURO SPAGWE2025-05-22
08056446901106NExT-DOCKINGEB NEURO SPAGWE2025-05-22
08056446901113NExT-PADEB NEURO SPAGWE2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWE2025-05-22
08056446901137NExT-HSEB NEURO SPAGWE2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWE2025-05-22
08056446901199NExT-ASEB NEURO SPAGWE2025-05-22
08056446901205NExT StationEB NEURO SPAGWE2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWE2025-05-19
08056446900185USB FLASH ADAPTER CABLE L=3mEB NEURO SPAGWE2024-12-04
08056446900192USB FLASH ADAPTER CABLE L=5mEB NEURO SPAGWE2024-12-04
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103982Sierra SummitCADWELL INDUSTRIES, INC.GWE2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.GWE2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-06-21
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102909Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04
00840067102916Cadwell GuardianCADWELL INDUSTRIES, INC.GWE2024-03-04