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)

TA-10 PORTABLE SCREENING AUDIOMETER

K-Number: K791467 · 1979-09-28

ApplicantTeledyne Avionics Div. of Teledyne
Decision Date1979-09-28
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TA-10 PORTABLE SCREENING 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 1979-09-28 under 510(k) number K791467. 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-10 PORTABLE SCREENING AUDIOMETER?

TA-10 PORTABLE SCREENING AUDIOMETER is a medical device that received FDA 510(k) clearance on 1979-09-28. The listed applicant is Teledyne Avionics Div. of Teledyne. The 510(k) number is K791467.

When did TA-10 PORTABLE SCREENING AUDIOMETER receive FDA 510(k) clearance?

TA-10 PORTABLE SCREENING AUDIOMETER received FDA 510(k) clearance on 1979-09-28, under 510(k) number K791467.

Who is the listed applicant for TA-10 PORTABLE SCREENING 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-10 PORTABLE SCREENING AUDIOMETER?

The FDA product code for TA-10 PORTABLE SCREENING 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 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

View all 13 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.

↑