DELPHI-MD System Device

Primary DI
07290018971017
Brand
DELPHI-MD System Device
Company
QUANTALX NEUROSCIENCE LTD
Model
1
Published
2026-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
SFNNon-Invasive Evoked Response Brain Stimulator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SFNNon-Invasive Evoked Response Brain StimulatorNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN250002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN250002000Delphi-MD SystemQuantalx Neuroscience, Ltd.2025-08-20SFN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018971017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018971017072900189710177290018971017

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential graphic recording systemAn assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.

Regulatory Flags#

DUNS number
600237370
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018971024Delphi MCS Electrode Cap M/L12026-05-05
07290018971031Delphi MCS Electrode Cap M12026-05-05
07290018971048Delphi MCS Electrode Cap L12026-05-05
07290018971055Delphi MCS Electrode Cap L/XL12026-05-05