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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 the device name listed in this FDA 510(k) record. The listed applicant is Quantalx Neuroscience. It received FDA 510(k) clearance on 2024-11-05 under 510(k) 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. The listed applicant is Quantalx Neuroscience. The 510(k) number is K242345.

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

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

Who is the listed applicant for Delphi Stimulator?

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

What is the FDA product code for Delphi Stimulator?

The FDA product code for Delphi Stimulator is GWF.

Other records listing Quantalx Neuroscience as applicant

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.

K243243Delphi MCS Electrode Cap

Related Devices (Code: GWF)

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.

K253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK234092SafeOp 3: Neural Informatix SysteemAlphatec Spine, Inc.K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)Soterix Medical, Inc.

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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