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FDA 510(k)

GALILEO EVOKED POTENTIALRE

K-Number: K963662 · 1997-02-26

ApplicantBiosound, Inc.
Decision Date1997-02-26
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GALILEO EVOKED POTENTIALRE is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1997-02-26 under 510(k) number K963662. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALILEO EVOKED POTENTIALRE?

GALILEO EVOKED POTENTIALRE is a medical device that received FDA 510(k) clearance on 1997-02-26. The listed applicant is Biosound, Inc.. The 510(k) number is K963662.

When did GALILEO EVOKED POTENTIALRE receive FDA 510(k) clearance?

GALILEO EVOKED POTENTIALRE received FDA 510(k) clearance on 1997-02-26, under 510(k) number K963662.

Who is the listed applicant for GALILEO EVOKED POTENTIALRE?

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 GALILEO EVOKED POTENTIALRE?

The FDA product code for GALILEO EVOKED POTENTIALRE is GWF.

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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 MK953716INTRACAVITY TRANSDUCERSK953530DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-AK953819DIAGNOSTIC ULTRASOUND TRANDUCER

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Related Devices (Code: GWF)

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.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

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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