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FDA 510(k)

YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH

K-Number: K923894 · 1993-03-10

ApplicantBiosound, Inc.
Decision Date1993-03-10
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

YHE GALILEO PLEIADE 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 1993-03-10 under 510(k) number K923894. 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 YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH?

YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH is a medical device that received FDA 510(k) clearance on 1993-03-10. The listed applicant is Biosound, Inc.. The 510(k) number is K923894.

When did YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH receive FDA 510(k) clearance?

YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH received FDA 510(k) clearance on 1993-03-10, under 510(k) number K923894.

Who is the listed applicant for YHE GALILEO PLEIADE 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 YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH?

The FDA product code for YHE GALILEO PLEIADE 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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