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FDA 510(k)

NEUROREADER

K-Number: K950986 · 1995-11-09

ApplicantArtronics
Decision Date1995-11-09
Product CodeHCS
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROREADER is the device name listed in this FDA 510(k) record. The listed applicant is Artronics. It received FDA 510(k) clearance on 1995-11-09 under 510(k) number K950986. The device is classified under product code HCS. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROREADER?

NEUROREADER is a medical device that received FDA 510(k) clearance on 1995-11-09. The listed applicant is Artronics. The 510(k) number is K950986.

When did NEUROREADER receive FDA 510(k) clearance?

NEUROREADER received FDA 510(k) clearance on 1995-11-09, under 510(k) number K950986.

Who is the listed applicant for NEUROREADER?

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

What is the FDA product code for NEUROREADER?

The FDA product code for NEUROREADER is HCS.

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Related Devices (Code: HCS)

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.

K981805POS T-7000Pos Technologies, Inc.K974208TYTRON C-3000Titronics Research & Development Co.K894772THERMALGRAPHIC ANALYSERMedtech InstrumentsK840487T-METERK.J. ElectronicsK831995TRENDO-SCOPEGabriel Ent.K822795GABRIEL DIGITRENDGabriel Ent.

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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