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FDA 510(k)

NEURO-AIDE

K-Number: K942926 · 1994-08-03

ApplicantBurke Neutech, Inc.
Decision Date1994-08-03
Product CodeGWY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEURO-AIDE is the device name listed in this FDA 510(k) record. The listed applicant is Burke Neutech, Inc.. It received FDA 510(k) clearance on 1994-08-03 under 510(k) number K942926. The device is classified under product code GWY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEURO-AIDE?

NEURO-AIDE is a medical device that received FDA 510(k) clearance on 1994-08-03. The listed applicant is Burke Neutech, Inc.. The 510(k) number is K942926.

When did NEURO-AIDE receive FDA 510(k) clearance?

NEURO-AIDE received FDA 510(k) clearance on 1994-08-03, under 510(k) number K942926.

Who is the listed applicant for NEURO-AIDE?

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

What is the FDA product code for NEURO-AIDE?

The FDA product code for NEURO-AIDE is GWY.

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Other records listing Burke Neutech, 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.

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Related Devices (Code: GWY)

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.

K050313BIS SRS (SEMI-RESUABLE SENSOR)Aspect Medical Systems, Inc.K871167SENSITESTERDexin Pty. , Ltd.K8517491-380 PINWHEEL (WARTENBERG)ArtiberiaK780422PINWHEELProjects IN Health

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.

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