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)

AUDIOSCREENER OAE

K-Number: K000184 · 2000-02-11

ApplicantKedly, Inc.
Decision Date2000-02-11
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOSCREENER OAE is the device name listed in this FDA 510(k) record. The listed applicant is Kedly, Inc.. It received FDA 510(k) clearance on 2000-02-11 under 510(k) number K000184. 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 AUDIOSCREENER OAE?

AUDIOSCREENER OAE is a medical device that received FDA 510(k) clearance on 2000-02-11. The listed applicant is Kedly, Inc.. The 510(k) number is K000184.

When did AUDIOSCREENER OAE receive FDA 510(k) clearance?

AUDIOSCREENER OAE received FDA 510(k) clearance on 2000-02-11, under 510(k) number K000184.

Who is the listed applicant for AUDIOSCREENER OAE?

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

What is the FDA product code for AUDIOSCREENER OAE?

The FDA product code for AUDIOSCREENER OAE 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 Kedly, 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.

K001058AUDIOSCREENER OAE + ABR

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.

↑