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FDA 510(k)

TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200

K-Number: K851392 · 1985-06-20

Decision Date1985-06-20
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 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 1985-06-20 under 510(k) number K851392. 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 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200?

TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 is a medical device that received FDA 510(k) clearance on 1985-06-20. The listed applicant is Tracor Instruments, Inc.. The 510(k) number is K851392.

When did TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 receive FDA 510(k) clearance?

TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 received FDA 510(k) clearance on 1985-06-20, under 510(k) number K851392.

Who is the listed applicant for TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200?

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 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200?

The FDA product code for TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200 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.

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.

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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.

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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