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FDA 510(k)

EQUINOX DIGITAL EEG SYSTEM

K-Number: K962447 · 1996-12-12

ApplicantPhysiometrix, Inc.
Decision Date1996-12-12
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EQUINOX DIGITAL EEG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Physiometrix, Inc.. It received FDA 510(k) clearance on 1996-12-12 under 510(k) number K962447. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EQUINOX DIGITAL EEG SYSTEM?

EQUINOX DIGITAL EEG SYSTEM is a medical device that received FDA 510(k) clearance on 1996-12-12. The listed applicant is Physiometrix, Inc.. The 510(k) number is K962447.

When did EQUINOX DIGITAL EEG SYSTEM receive FDA 510(k) clearance?

EQUINOX DIGITAL EEG SYSTEM received FDA 510(k) clearance on 1996-12-12, under 510(k) number K962447.

Who is the listed applicant for EQUINOX DIGITAL EEG SYSTEM?

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

What is the FDA product code for EQUINOX DIGITAL EEG SYSTEM?

The FDA product code for EQUINOX DIGITAL EEG SYSTEM is GWQ.

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Other records listing Physiometrix, Inc. as applicant

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Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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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