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FDA 510(k)

ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER

K-Number: K890124 · 1989-07-14

ApplicantGrason-Stadler, Inc.
Decision Date1989-07-14
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ILO88 OTODYNAMIC ANALYZER SCREENING 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 1989-07-14 under 510(k) number K890124. 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 ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER?

ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Grason-Stadler, Inc.. The 510(k) number is K890124.

When did ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER receive FDA 510(k) clearance?

ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER received FDA 510(k) clearance on 1989-07-14, under 510(k) number K890124.

Who is the listed applicant for ILO88 OTODYNAMIC ANALYZER SCREENING 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 ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER?

The FDA product code for ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER is EWO.

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Other records listing Grason-Stadler, Inc. as applicant

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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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