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FDA 510(k)

PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE

K-Number: K951507 · 1995-07-14

ApplicantNeuroconcepts, Inc.
Decision Date1995-07-14
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Neuroconcepts, Inc.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K951507. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE?

PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Neuroconcepts, Inc.. The 510(k) number is K951507.

When did PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE receive FDA 510(k) clearance?

PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE received FDA 510(k) clearance on 1995-07-14, under 510(k) number K951507.

Who is the listed applicant for PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE?

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

What is the FDA product code for PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE?

The FDA product code for PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE is GWQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Neuroconcepts, Inc. 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.

K951724QUANTITATIVE EEG ANALYSIS SOFTWAREK905435UNIQUANT

Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

Official Source

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