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FDA 510(k)

ER35 ERO-SCAN PRO HEARING TEST SYSTEM

K-Number: K070880 · 2007-06-07

ApplicantEtymotic Research, Inc.
Decision Date2007-06-07
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ER35 ERO-SCAN PRO HEARING TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Etymotic Research, Inc.. It received FDA 510(k) clearance on 2007-06-07 under 510(k) number K070880. 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 ER35 ERO-SCAN PRO HEARING TEST SYSTEM?

ER35 ERO-SCAN PRO HEARING TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-07. The listed applicant is Etymotic Research, Inc.. The 510(k) number is K070880.

When did ER35 ERO-SCAN PRO HEARING TEST SYSTEM receive FDA 510(k) clearance?

ER35 ERO-SCAN PRO HEARING TEST SYSTEM received FDA 510(k) clearance on 2007-06-07, under 510(k) number K070880.

Who is the listed applicant for ER35 ERO-SCAN PRO HEARING TEST SYSTEM?

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

What is the FDA product code for ER35 ERO-SCAN PRO HEARING TEST SYSTEM?

The FDA product code for ER35 ERO-SCAN PRO HEARING TEST SYSTEM 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 Etymotic Research, 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.

K112733ER35 ERO-SCAN PRO HEARING TEST SYSTEM

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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