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FDA 510(k)

NEUROMETRIC ANALYSIS SYSTEM

K-Number: K974748 · 1998-07-10

ApplicantNxlink, Ltd.
Decision Date1998-07-10
Product CodeOLU
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROMETRIC ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nxlink, Ltd.. It received FDA 510(k) clearance on 1998-07-10 under 510(k) number K974748. 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 NEUROMETRIC ANALYSIS SYSTEM?

NEUROMETRIC ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-10. The listed applicant is Nxlink, Ltd.. The 510(k) number is K974748.

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

NEUROMETRIC ANALYSIS SYSTEM received FDA 510(k) clearance on 1998-07-10, under 510(k) number K974748.

Who is the listed applicant for NEUROMETRIC ANALYSIS SYSTEM?

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

What is the FDA product code for NEUROMETRIC ANALYSIS SYSTEM?

The FDA product code for NEUROMETRIC ANALYSIS SYSTEM is OLU.

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.

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.

Official Source

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