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)

RION DIAGNOSTIC AUDIOMETER

K-Number: K802207 · 1980-09-26

ApplicantRion Acoustic Instruments, Inc.
Decision Date1980-09-26
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RION DIAGNOSTIC AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Rion Acoustic Instruments, Inc.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802207. 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 RION DIAGNOSTIC AUDIOMETER?

RION DIAGNOSTIC AUDIOMETER is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Rion Acoustic Instruments, Inc.. The 510(k) number is K802207.

When did RION DIAGNOSTIC AUDIOMETER receive FDA 510(k) clearance?

RION DIAGNOSTIC AUDIOMETER received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802207.

Who is the listed applicant for RION DIAGNOSTIC AUDIOMETER?

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

What is the FDA product code for RION DIAGNOSTIC AUDIOMETER?

The FDA product code for RION DIAGNOSTIC 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 Rion Acoustic 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.

K874510RIONET HEARING AID HB-75K862670RIONET HEARING AID HB-35PTK861728RIONET HEARING AIDK853637RIONET HEARING AID HI-07K853636RIONET HEARING AID HI-06K853638RIONET HEARING AID

View all 51 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.

↑