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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 the device name listed in this FDA 510(k) record. The listed applicant is Quantalx Neroscience. It received FDA 510(k) clearance on 2025-03-12 under 510(k) 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. The listed applicant is Quantalx Neroscience. The 510(k) number is K243746.

When did Delphi Amplifier receive FDA 510(k) clearance?

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

Who is the listed applicant for Delphi Amplifier?

The FDA 510(k) record lists Quantalx Neroscience as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Delphi Amplifier?

The FDA product code for Delphi Amplifier is GWL.

Related Devices (Code: GWL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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