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FDA 510(k)

AUDIOMETER

K-Number: K843618 · 1984-12-03

ApplicantGrason-Stadler, Inc.
Decision Date1984-12-03
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

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 1984-12-03 under 510(k) number K843618. 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 AUDIOMETER?

AUDIOMETER is a medical device that received FDA 510(k) clearance on 1984-12-03. The listed applicant is Grason-Stadler, Inc.. The 510(k) number is K843618.

When did AUDIOMETER receive FDA 510(k) clearance?

AUDIOMETER received FDA 510(k) clearance on 1984-12-03, under 510(k) number K843618.

Who is the listed applicant for 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 AUDIOMETER?

The FDA product code for 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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