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FDA 510(k)

TRACOR RA500 AUDIOMETER

K-Number: K891373 · 1989-07-14

ApplicantTracor Instruments Austin, Inc.
Decision Date1989-07-14
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TRACOR RA500 AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Tracor Instruments Austin, Inc.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K891373. 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 RA500 AUDIOMETER?

TRACOR RA500 AUDIOMETER is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Tracor Instruments Austin, Inc.. The 510(k) number is K891373.

When did TRACOR RA500 AUDIOMETER receive FDA 510(k) clearance?

TRACOR RA500 AUDIOMETER received FDA 510(k) clearance on 1989-07-14, under 510(k) number K891373.

Who is the listed applicant for TRACOR RA500 AUDIOMETER?

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

What is the FDA product code for TRACOR RA500 AUDIOMETER?

The FDA product code for TRACOR RA500 AUDIOMETER is EWO.

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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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