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FDA 510(k)

OTO WIZZARD

K-Number: K981511 · 1998-07-24

ApplicantMedrx, Inc.
Decision Date1998-07-24
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTO WIZZARD is the device name listed in this FDA 510(k) record. The listed applicant is Medrx, Inc.. It received FDA 510(k) clearance on 1998-07-24 under 510(k) number K981511. 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 OTO WIZZARD?

OTO WIZZARD is a medical device that received FDA 510(k) clearance on 1998-07-24. The listed applicant is Medrx, Inc.. The 510(k) number is K981511.

When did OTO WIZZARD receive FDA 510(k) clearance?

OTO WIZZARD received FDA 510(k) clearance on 1998-07-24, under 510(k) number K981511.

Who is the listed applicant for OTO WIZZARD?

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

What is the FDA product code for OTO WIZZARD?

The FDA product code for OTO WIZZARD is EWO.

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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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