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FDA 510(k)

AUDIOSCAN

K-Number: K926336 · 1993-03-04

ApplicantElectrocaine Medical System
Decision Date1993-03-04
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIOSCAN is the device name listed in this FDA 510(k) record. The listed applicant is Electrocaine Medical System. It received FDA 510(k) clearance on 1993-03-04 under 510(k) number K926336. 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 AUDIOSCAN?

AUDIOSCAN is a medical device that received FDA 510(k) clearance on 1993-03-04. The listed applicant is Electrocaine Medical System. The 510(k) number is K926336.

When did AUDIOSCAN receive FDA 510(k) clearance?

AUDIOSCAN received FDA 510(k) clearance on 1993-03-04, under 510(k) number K926336.

Who is the listed applicant for AUDIOSCAN?

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

What is the FDA product code for AUDIOSCAN?

The FDA product code for AUDIOSCAN 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.

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Other records listing Electrocaine Medical System 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.

K924413FLOWSCANK844638ELECTROCAINE MODEL SR-IVK830992XCEL MODEL XE-1K800317DAVOL EMS ADAPTER, CAT. NO. 13-7664

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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