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FDA 510(k)

TRACOR RA400 AUDIOMETER

K-Number: K822414 · 1982-08-30

ApplicantTracor Instruments, Inc.
Decision Date1982-08-30
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TRACOR RA400 AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Tracor Instruments, Inc.. It received FDA 510(k) clearance on 1982-08-30 under 510(k) number K822414. 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 TRACOR RA400 AUDIOMETER?

TRACOR RA400 AUDIOMETER is a medical device that received FDA 510(k) clearance on 1982-08-30. The listed applicant is Tracor Instruments, Inc.. The 510(k) number is K822414.

When did TRACOR RA400 AUDIOMETER receive FDA 510(k) clearance?

TRACOR RA400 AUDIOMETER received FDA 510(k) clearance on 1982-08-30, under 510(k) number K822414.

Who is the listed applicant for TRACOR RA400 AUDIOMETER?

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

What is the FDA product code for TRACOR RA400 AUDIOMETER?

The FDA product code for TRACOR RA400 AUDIOMETER is EWO.

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Other records listing Tracor Instruments, 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.

K853245TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETERK851392TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200K790903TRACOR MODEL RA-411 MICROPROCESSORK781743RESPONSE SYSTEM, TN-3000K781704STIMULATOR, TN-3001 SOMATOSENSORYK780749SPEECH AUDIOMETER RA 226

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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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