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FDA 510(k)

GSI 65 COMPUTERIZED AUDIOMETER

K-Number: K951759 · 1995-07-06

ApplicantGrason-Stadler, Inc.
Decision Date1995-07-06
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GSI 65 COMPUTERIZED AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Grason-Stadler, Inc.. It received FDA 510(k) clearance on 1995-07-06 under 510(k) number K951759. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSI 65 COMPUTERIZED AUDIOMETER?

GSI 65 COMPUTERIZED AUDIOMETER is a medical device that received FDA 510(k) clearance on 1995-07-06. The listed applicant is Grason-Stadler, Inc.. The 510(k) number is K951759.

When did GSI 65 COMPUTERIZED AUDIOMETER receive FDA 510(k) clearance?

GSI 65 COMPUTERIZED AUDIOMETER received FDA 510(k) clearance on 1995-07-06, under 510(k) number K951759.

Who is the listed applicant for GSI 65 COMPUTERIZED AUDIOMETER?

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

What is the FDA product code for GSI 65 COMPUTERIZED AUDIOMETER?

The FDA product code for GSI 65 COMPUTERIZED AUDIOMETER is EWO.

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Other records listing Grason-Stadler, 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.

K180287GSI CortiK172403GSI NovusK000097GSI 2000 MIDDLE EAR ANALYZERK974237GSI 70 AUDIOPATH SCREENERK970324GSI SA60 DPOAE SYSTEMK953684GSI 61 CLINICAL AUDIOMETER

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Related Devices (Code: EWO)

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.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, 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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