Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER

K-Number: K853245 · 1985-10-16

ApplicantTracor Instruments, Inc.
Decision Date1985-10-16
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TRACOR MODEL RA600 MICROPROCESSOR 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 1985-10-16 under 510(k) number K853245. 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 MODEL RA600 MICROPROCESSOR AUDIOMETER?

TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Tracor Instruments, Inc.. The 510(k) number is K853245.

When did TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER receive FDA 510(k) clearance?

TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853245.

Who is the listed applicant for TRACOR MODEL RA600 MICROPROCESSOR 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 MODEL RA600 MICROPROCESSOR AUDIOMETER?

The FDA product code for TRACOR MODEL RA600 MICROPROCESSOR 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K851392TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 200K822414TRACOR RA400 AUDIOMETERK790903TRACOR MODEL RA-411 MICROPROCESSORK781743RESPONSE SYSTEM, TN-3000K781704STIMULATOR, TN-3001 SOMATOSENSORYK780749SPEECH AUDIOMETER RA 226

View all 10 devices →

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.

↑