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)

AUDIOMETER DIGITAL HEARING SYSTEM

K-Number: K884044 · 1989-02-22

ApplicantResound Corp.
Decision Date1989-02-22
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOMETER DIGITAL HEARING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Resound Corp.. It received FDA 510(k) clearance on 1989-02-22 under 510(k) number K884044. 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 AUDIOMETER DIGITAL HEARING SYSTEM?

AUDIOMETER DIGITAL HEARING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-02-22. The listed applicant is Resound Corp.. The 510(k) number is K884044.

When did AUDIOMETER DIGITAL HEARING SYSTEM receive FDA 510(k) clearance?

AUDIOMETER DIGITAL HEARING SYSTEM received FDA 510(k) clearance on 1989-02-22, under 510(k) number K884044.

Who is the listed applicant for AUDIOMETER DIGITAL HEARING SYSTEM?

The FDA 510(k) record lists Resound Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUDIOMETER DIGITAL HEARING SYSTEM?

The FDA product code for AUDIOMETER DIGITAL HEARING SYSTEM 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 Resound Corp. 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.

K984547DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDSK974081RESOUND STEALTH CICK974257RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)K971605RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTIONK970215AUDALLION II HEARING SYSTEMK964557RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION

View all 41 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.

↑