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FDA 510(k)

DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER

K-Number: K943215 · 1995-05-12

ApplicantKenneth Ullrich
Decision Date1995-05-12
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER is the device name listed in this FDA 510(k) record. The listed applicant is Kenneth Ullrich. It received FDA 510(k) clearance on 1995-05-12 under 510(k) number K943215. 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 DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER?

DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Kenneth Ullrich. The 510(k) number is K943215.

When did DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER receive FDA 510(k) clearance?

DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER received FDA 510(k) clearance on 1995-05-12, under 510(k) number K943215.

Who is the listed applicant for DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER?

The FDA 510(k) record lists Kenneth Ullrich as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER?

The FDA product code for DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER is EWO.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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