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)

ILO292 DP ECHOPORT PLUS OAE SYSTEM

K-Number: K983350 · 1998-12-11

ApplicantOtodynamics, Ltd.
Decision Date1998-12-11
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ILO292 DP ECHOPORT PLUS OAE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Otodynamics, Ltd.. It received FDA 510(k) clearance on 1998-12-11 under 510(k) number K983350. 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 ILO292 DP ECHOPORT PLUS OAE SYSTEM?

ILO292 DP ECHOPORT PLUS OAE SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Otodynamics, Ltd.. The 510(k) number is K983350.

When did ILO292 DP ECHOPORT PLUS OAE SYSTEM receive FDA 510(k) clearance?

ILO292 DP ECHOPORT PLUS OAE SYSTEM received FDA 510(k) clearance on 1998-12-11, under 510(k) number K983350.

Who is the listed applicant for ILO292 DP ECHOPORT PLUS OAE SYSTEM?

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

What is the FDA product code for ILO292 DP ECHOPORT PLUS OAE SYSTEM?

The FDA product code for ILO292 DP ECHOPORT PLUS OAE 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 Otodynamics, Ltd. 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.

K240430Otoport ProK072033OTODYNAMICS OTOPORTK983351ILO292 DP ECHOPORT PLUS OAE SYSTEMK983352ILO2088 ENCHOCHECK OR ILO2088 OTOCHECKK962995ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC

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.

↑