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FDA 510(k)

TA-201 CLINICAL AUDIOMETER

K-Number: K844069 · 1984-12-03

ApplicantTeledyne Avionics Div. of Teledyne
Decision Date1984-12-03
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TA-201 CLINICAL AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Teledyne Avionics Div. of Teledyne. It received FDA 510(k) clearance on 1984-12-03 under 510(k) number K844069. 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 TA-201 CLINICAL AUDIOMETER?

TA-201 CLINICAL AUDIOMETER is a medical device that received FDA 510(k) clearance on 1984-12-03. The listed applicant is Teledyne Avionics Div. of Teledyne. The 510(k) number is K844069.

When did TA-201 CLINICAL AUDIOMETER receive FDA 510(k) clearance?

TA-201 CLINICAL AUDIOMETER received FDA 510(k) clearance on 1984-12-03, under 510(k) number K844069.

Who is the listed applicant for TA-201 CLINICAL AUDIOMETER?

The FDA 510(k) record lists Teledyne Avionics Div. of Teledyne as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TA-201 CLINICAL AUDIOMETER?

The FDA product code for TA-201 CLINICAL AUDIOMETER is EWO.

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Other records listing Teledyne Avionics Div. of Teledyne 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.

K860262TA-6C - PART NUMBER SLZ 7520K860522SPIROMETER, MODEL TS-1000, PART NO. SLZ7504K855068SPIROMETER, MODEL TS-500 PART #SLZ7534K855070SPIROMETER MODEL TS-200 SLZ 7541K855069SPIROMETER TS-400 SLZ 7547K854043AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B

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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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