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FDA 510(k)

THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH

K-Number: K923950 · 1993-01-26

ApplicantBiosound, Inc.
Decision Date1993-01-26
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1993-01-26 under 510(k) number K923950. 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 THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH?

THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH is a medical device that received FDA 510(k) clearance on 1993-01-26. The listed applicant is Biosound, Inc.. The 510(k) number is K923950.

When did THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH receive FDA 510(k) clearance?

THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH received FDA 510(k) clearance on 1993-01-26, under 510(k) number K923950.

Who is the listed applicant for THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH?

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

What is the FDA product code for THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH?

The FDA product code for THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH is GWQ.

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Other records listing Biosound, 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.

K971700BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCERK963936ACCESSPOINT, MED E-MAIL, DICOM READERK963262ARTOSCAN MK963662GALILEO EVOKED POTENTIALREK953716INTRACAVITY TRANSDUCERSK953530DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A

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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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