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FDA 510(k)

GLASER RT60, RT80, RT150 AUDIOMETER

K-Number: K934343 · 1994-01-21

ApplicantGlaser Instruments AG
Decision Date1994-01-21
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

GLASER RT60, RT80, RT150 AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Glaser Instruments AG. It received FDA 510(k) clearance on 1994-01-21 under 510(k) number K934343. 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 GLASER RT60, RT80, RT150 AUDIOMETER?

GLASER RT60, RT80, RT150 AUDIOMETER is a medical device that received FDA 510(k) clearance on 1994-01-21. The listed applicant is Glaser Instruments AG. The 510(k) number is K934343.

When did GLASER RT60, RT80, RT150 AUDIOMETER receive FDA 510(k) clearance?

GLASER RT60, RT80, RT150 AUDIOMETER received FDA 510(k) clearance on 1994-01-21, under 510(k) number K934343.

Who is the listed applicant for GLASER RT60, RT80, RT150 AUDIOMETER?

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

What is the FDA product code for GLASER RT60, RT80, RT150 AUDIOMETER?

The FDA product code for GLASER RT60, RT80, RT150 AUDIOMETER is EWO.

Related Clinical Trials

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.

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Other records listing Glaser Instruments AG 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.

K934342GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM

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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