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)

QUIK-CAP

K-Number: K000865 · 2000-04-18

ApplicantNeuroscan
Decision Date2000-04-18
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

QUIK-CAP is the device name listed in this FDA 510(k) record. The listed applicant is Neuroscan. It received FDA 510(k) clearance on 2000-04-18 under 510(k) number K000865. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUIK-CAP?

QUIK-CAP is a medical device that received FDA 510(k) clearance on 2000-04-18. The listed applicant is Neuroscan. The 510(k) number is K000865.

When did QUIK-CAP receive FDA 510(k) clearance?

QUIK-CAP received FDA 510(k) clearance on 2000-04-18, under 510(k) number K000865.

Who is the listed applicant for QUIK-CAP?

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

What is the FDA product code for QUIK-CAP?

The FDA product code for QUIK-CAP is GXY.

Other records listing Neuroscan 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.

K023771SYNAMPS2K023536NUAMPS

Related Devices (Code: GXY)

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.

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,LtdK260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed Europe

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.

↑