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)

ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID

K-Number: K904544 · 1990-10-31

ApplicantQualitone
Decision Date1990-10-31
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID is the device name listed in this FDA 510(k) record. The listed applicant is Qualitone. It received FDA 510(k) clearance on 1990-10-31 under 510(k) number K904544. 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 ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID?

ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID is a medical device that received FDA 510(k) clearance on 1990-10-31. The listed applicant is Qualitone. The 510(k) number is K904544.

When did ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID receive FDA 510(k) clearance?

ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID received FDA 510(k) clearance on 1990-10-31, under 510(k) number K904544.

Who is the listed applicant for ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID?

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

What is the FDA product code for ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID?

The FDA product code for ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID 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 Qualitone 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.

K961827IN-THE-EARK955466DYNAMEQ-II OPTIONK955359CYBER III OPTION UM, UC312, UC10, UCICK953884PROPHETK935348ODYSSEY CLINICAL AUDIOMETERK935289PRO FIT-CYBER II OPTION

View all 39 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.

↑