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FDA 510(k)

Delphi Amplifier

K-Number: K243746 · 2025-03-12

ApplicantQuantalx Neroscience
Decision Date2025-03-12
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Delphi Amplifier is a medical device manufactured by Quantalx Neroscience. It received FDA 510(k) clearance on 2025-03-12 under approval number K243746. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Delphi Amplifier?

Delphi Amplifier is a medical device that received FDA 510(k) clearance on 2025-03-12. It is manufactured by Quantalx Neroscience. The 510(k) number is K243746.

When was Delphi Amplifier approved by the FDA?

Delphi Amplifier received FDA 510(k) clearance on 2025-03-12, under approval number K243746.

What company makes Delphi Amplifier?

Delphi Amplifier is manufactured by Quantalx Neroscience.

What is the FDA product code for Delphi Amplifier?

The FDA product code for Delphi Amplifier is GWL.

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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.

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