Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

UNIQUANT

K-Number: K905435 · 1991-07-22

ApplicantNeuroconcepts, Inc.
Decision Date1991-07-22
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

UNIQUANT is the device name listed in this FDA 510(k) record. The listed applicant is Neuroconcepts, Inc.. It received FDA 510(k) clearance on 1991-07-22 under 510(k) number K905435. 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 UNIQUANT?

UNIQUANT is a medical device that received FDA 510(k) clearance on 1991-07-22. The listed applicant is Neuroconcepts, Inc.. The 510(k) number is K905435.

When did UNIQUANT receive FDA 510(k) clearance?

UNIQUANT received FDA 510(k) clearance on 1991-07-22, under 510(k) number K905435.

Who is the listed applicant for UNIQUANT?

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 UNIQUANT?

The FDA product code for UNIQUANT 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.

K951507PRINCIPLE COMPONENT EEG ANALYSIS SOFTWAREK951724QUANTITATIVE EEG ANALYSIS SOFTWARE

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑