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FDA 510(k)

PHOENIX DIGITAL EEG SYSTEM

K-Number: K911229 · 1991-09-30

ApplicantDantec Medical, Inc.
Decision Date1991-09-30
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PHOENIX DIGITAL EEG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dantec Medical, Inc.. It received FDA 510(k) clearance on 1991-09-30 under 510(k) number K911229. 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 PHOENIX DIGITAL EEG SYSTEM?

PHOENIX DIGITAL EEG SYSTEM is a medical device that received FDA 510(k) clearance on 1991-09-30. The listed applicant is Dantec Medical, Inc.. The 510(k) number is K911229.

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

PHOENIX DIGITAL EEG SYSTEM received FDA 510(k) clearance on 1991-09-30, under 510(k) number K911229.

Who is the listed applicant for PHOENIX DIGITAL EEG SYSTEM?

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

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

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

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Other records listing Dantec Medical, 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.

K960503DANTEC DUETK950314DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)K953999DANTEC DA CAPOK926363MULTI-DOP SK931801MULTI-DOP XK930458MULTI-DOP L

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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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