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FDA 510(k)

ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC

K-Number: K962995 · 1997-01-10

ApplicantOtodynamics, Ltd.
Decision Date1997-01-10
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC is the device name listed in this FDA 510(k) record. The listed applicant is Otodynamics, Ltd.. It received FDA 510(k) clearance on 1997-01-10 under 510(k) number K962995. 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 ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC?

ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Otodynamics, Ltd.. The 510(k) number is K962995.

When did ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC receive FDA 510(k) clearance?

ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC received FDA 510(k) clearance on 1997-01-10, under 510(k) number K962995.

Who is the listed applicant for ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC?

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 ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC?

The FDA product code for ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC 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 OTOPORTK983350ILO292 DP ECHOPORT PLUS OAE SYSTEMK983351ILO292 DP ECHOPORT PLUS OAE SYSTEMK983352ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK

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.

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