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FDA 510(k)

ECHO-SCREEN

K-Number: K982642 · 1998-10-21

ApplicantFischer-Zoth Audiologic Systems, Inc.
Decision Date1998-10-21
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ECHO-SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Fischer-Zoth Audiologic Systems, Inc.. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K982642. 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 ECHO-SCREEN?

ECHO-SCREEN is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Fischer-Zoth Audiologic Systems, Inc.. The 510(k) number is K982642.

When did ECHO-SCREEN receive FDA 510(k) clearance?

ECHO-SCREEN received FDA 510(k) clearance on 1998-10-21, under 510(k) number K982642.

Who is the listed applicant for ECHO-SCREEN?

The FDA 510(k) record lists Fischer-Zoth Audiologic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHO-SCREEN?

The FDA product code for ECHO-SCREEN 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 Fischer-Zoth Audiologic Systems, 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.

K013977ECHO-SCREEN T, TA, TD, TDA, TC

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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