FDA 510(k)

CLINICAL AUDIOMETER MODEL TA-200

K-Number: K801325 · 1980-06-30

ApplicantTeledyne Avionics Div. of Teledyne

Decision Date1980-06-30

Product CodeEWO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

CLINICAL AUDIOMETER MODEL TA-200 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 1980-06-30 under 510(k) number K801325. 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 CLINICAL AUDIOMETER MODEL TA-200?

CLINICAL AUDIOMETER MODEL TA-200 is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is Teledyne Avionics Div. of Teledyne. The 510(k) number is K801325.

When did CLINICAL AUDIOMETER MODEL TA-200 receive FDA 510(k) clearance?

CLINICAL AUDIOMETER MODEL TA-200 received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801325.

Who is the listed applicant for CLINICAL AUDIOMETER MODEL TA-200?

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 CLINICAL AUDIOMETER MODEL TA-200?

The FDA product code for CLINICAL AUDIOMETER MODEL TA-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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Teledyne Avionics Div. of Teledyne as applicant

K860262TA-6C - PART NUMBER SLZ 7520 K860522SPIROMETER, MODEL TS-1000, PART NO. SLZ7504 K855068SPIROMETER, MODEL TS-500 PART #SLZ7534 K855070SPIROMETER MODEL TS-200 SLZ 7541 K855069SPIROMETER TS-400 SLZ 7547 K854043AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B

View all 13 devices →

Related Devices (Code: EWO)

K234095OtoNova/OtoNova ProOtodynamics K240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH K191372LyraInteracoustics A/S K180287GSI 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.