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K Number
K243243Device Name
Delphi MCS Electrode Cap
Manufacturer
QuantalX Neuroscience, Ltd.
Date Cleared
2025-02-06
(118 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
QuantalX Neuroscience, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Delphi MCS Electrode Cap is an EEG electrode set intended for routine clinical settings where rapid placement of large number of EEG electrodes is desired.
Device Description
The Delphi MCS Electrode Cap is made of elastic textile material, preserving the shape and size. The cap provides the exact position of the electrodes on the head without the need for additional measurements and adjustments. Large holes are provided for ventilation and access to the electrodes and patient's skin. The cap is fixed to the head with a chinstrap. The Cap is available in the following sizes: XL 60-66cm, XL/L 57-63cm, L 54-60cm, L/M 51-57cm, M 48-54cm. The textile caps sizes are identifiable by the color material or seam and marking according to international system 10-20.
The Ag/AgCl electrodes are designed to provide minimal polarization and long-term stability of the signal. The conductive surface of the electrodes which is housed inside the electrode base does not have direct skin contact; an electrically conductive substance (hydrogel) is used inside the electrode base for improved conductivity.
Delphi Cap electrodes are thin cup Ag/AgCl sintered electrode for EEG recording. The electrodes are designed for maximum comfort while the patient in a supine position. The design of this electrode is suitable for conducting combined TMS-EEG studies. The Ag/AgCl sintered electrode material guarantees minimum polarization and long-term signal stability, as well as an increased electrode life.
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