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FDA 510(k)

THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR

K-Number: K923860 · 1993-02-04

ApplicantBiosound, Inc.
Decision Date1993-02-04
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR is the device name listed in this FDA 510(k) record. The listed applicant is Biosound, Inc.. It received FDA 510(k) clearance on 1993-02-04 under 510(k) number K923860. 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 LINE -- PLANET 100, 200 & 300 & STAR?

THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR is a medical device that received FDA 510(k) clearance on 1993-02-04. The listed applicant is Biosound, Inc.. The 510(k) number is K923860.

When did THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR receive FDA 510(k) clearance?

THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR received FDA 510(k) clearance on 1993-02-04, under 510(k) number K923860.

Who is the listed applicant for THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR?

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 LINE -- PLANET 100, 200 & 300 & STAR?

The FDA product code for THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR 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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