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FDA 510(k)

Delphi Stimulator

K-Number: K242345 · 2024-11-05

ApplicantQuantalx Neuroscience
Decision Date2024-11-05
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Delphi Stimulator is a medical device manufactured by Quantalx Neuroscience. It received FDA 510(k) clearance on 2024-11-05 under approval number K242345. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Delphi Stimulator?

Delphi Stimulator is a medical device that received FDA 510(k) clearance on 2024-11-05. It is manufactured by Quantalx Neuroscience. The 510(k) number is K242345.

When was Delphi Stimulator approved by the FDA?

Delphi Stimulator received FDA 510(k) clearance on 2024-11-05, under approval number K242345.

What company makes Delphi Stimulator?

Delphi Stimulator is manufactured by Quantalx Neuroscience.

What is the FDA product code for Delphi Stimulator?

The FDA product code for Delphi Stimulator is GWF.

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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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