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)

NICOLETONE SYSTEM V32 AMPLIFIER

K-Number: K061908 · 2006-11-06

ApplicantViasys Neuro Care
Decision Date2006-11-06
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NICOLETONE SYSTEM V32 AMPLIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Viasys Neuro Care. It received FDA 510(k) clearance on 2006-11-06 under 510(k) number K061908. 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 NICOLETONE SYSTEM V32 AMPLIFIER?

NICOLETONE SYSTEM V32 AMPLIFIER is a medical device that received FDA 510(k) clearance on 2006-11-06. The listed applicant is Viasys Neuro Care. The 510(k) number is K061908.

When did NICOLETONE SYSTEM V32 AMPLIFIER receive FDA 510(k) clearance?

NICOLETONE SYSTEM V32 AMPLIFIER received FDA 510(k) clearance on 2006-11-06, under 510(k) number K061908.

Who is the listed applicant for NICOLETONE SYSTEM V32 AMPLIFIER?

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

What is the FDA product code for NICOLETONE SYSTEM V32 AMPLIFIER?

The FDA product code for NICOLETONE SYSTEM V32 AMPLIFIER 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 Viasys Neuro Care 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.

K053648PIONEER TC8080, COMPANION III

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.

↑