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FDA 510(k)

OTOGRAM, CA3350

K-Number: K070118 · 2007-03-07

ApplicantTympany, Inc.
Decision Date2007-03-07
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOGRAM, CA3350 is the device name listed in this FDA 510(k) record. The listed applicant is Tympany, Inc.. It received FDA 510(k) clearance on 2007-03-07 under 510(k) number K070118. 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 OTOGRAM, CA3350?

OTOGRAM, CA3350 is a medical device that received FDA 510(k) clearance on 2007-03-07. The listed applicant is Tympany, Inc.. The 510(k) number is K070118.

When did OTOGRAM, CA3350 receive FDA 510(k) clearance?

OTOGRAM, CA3350 received FDA 510(k) clearance on 2007-03-07, under 510(k) number K070118.

Who is the listed applicant for OTOGRAM, CA3350?

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

What is the FDA product code for OTOGRAM, CA3350?

The FDA product code for OTOGRAM, CA3350 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 Tympany, 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.

K041853OTOGRAM

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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