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FDA 510(k)

MODEL 330 SCREENING AUDIOMETER

K-Number: K911689 · 1991-10-21

ApplicantVirtual Corp.
Decision Date1991-10-21
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL 330 SCREENING AUDIOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Virtual Corp.. It received FDA 510(k) clearance on 1991-10-21 under 510(k) number K911689. 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 MODEL 330 SCREENING AUDIOMETER?

MODEL 330 SCREENING AUDIOMETER is a medical device that received FDA 510(k) clearance on 1991-10-21. The listed applicant is Virtual Corp.. The 510(k) number is K911689.

When did MODEL 330 SCREENING AUDIOMETER receive FDA 510(k) clearance?

MODEL 330 SCREENING AUDIOMETER received FDA 510(k) clearance on 1991-10-21, under 510(k) number K911689.

Who is the listed applicant for MODEL 330 SCREENING AUDIOMETER?

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

What is the FDA product code for MODEL 330 SCREENING AUDIOMETER?

The FDA product code for MODEL 330 SCREENING AUDIOMETER is EWO.

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Other records listing Virtual Corp. 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.

K960500THE VIRTUAL M-332K934715MODEL 222 CLINICAL AUDIOMETERK930203MODEL 322 CLINICAL AUDIOMETERK926574MODEL 330 SCREENING AUDIO METER, MODIFIEDK896301MODEL 340 PROBE MIC SYSTEMK895443MODEL 210 IMPEDANCE SYSTEM

View all 9 devices →

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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