Delphi MCS Electrode Cap
K-Number: K243243 · 2025-02-06
ApplicantQuantalx Neuroscience, Ltd.
Decision Date2025-02-06
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Delphi MCS Electrode Cap is a medical device manufactured by Quantalx Neuroscience, Ltd.. It received FDA 510(k) clearance on 2025-02-06 under approval number K243243. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Delphi MCS Electrode Cap?
Delphi MCS Electrode Cap is a medical device that received FDA 510(k) clearance on 2025-02-06. It is manufactured by Quantalx Neuroscience, Ltd.. The 510(k) number is K243243.
When was Delphi MCS Electrode Cap approved by the FDA?
Delphi MCS Electrode Cap received FDA 510(k) clearance on 2025-02-06, under approval number K243243.
What company makes Delphi MCS Electrode Cap?
Delphi MCS Electrode Cap is manufactured by Quantalx Neuroscience, Ltd..
What is the FDA product code for Delphi MCS Electrode Cap?
The FDA product code for Delphi MCS Electrode Cap is GXY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.