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FDA 510(k)

NEUROGUIDE ANALYSIS SYSTEM

K-Number: K041263 · 2004-08-03

ApplicantApplied Neuroscience, Inc.
Decision Date2004-08-03
Product CodeOLU
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROGUIDE ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Applied Neuroscience, Inc.. It received FDA 510(k) clearance on 2004-08-03 under 510(k) number K041263. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROGUIDE ANALYSIS SYSTEM?

NEUROGUIDE ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-03. The listed applicant is Applied Neuroscience, Inc.. The 510(k) number is K041263.

When did NEUROGUIDE ANALYSIS SYSTEM receive FDA 510(k) clearance?

NEUROGUIDE ANALYSIS SYSTEM received FDA 510(k) clearance on 2004-08-03, under 510(k) number K041263.

Who is the listed applicant for NEUROGUIDE ANALYSIS SYSTEM?

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

What is the FDA product code for NEUROGUIDE ANALYSIS SYSTEM?

The FDA product code for NEUROGUIDE ANALYSIS SYSTEM is OLU.

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Related Devices (Code: OLU)

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.

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Official Source

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

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