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FDA 510(k)

Eclipse with VEMP

K-Number: K162037 · 2017-03-23

ApplicantInteracoustics A/S
Decision Date2017-03-23
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Eclipse with VEMP is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics A/S. It received FDA 510(k) clearance on 2017-03-23 under 510(k) number K162037. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eclipse with VEMP?

Eclipse with VEMP is a medical device that received FDA 510(k) clearance on 2017-03-23. The listed applicant is Interacoustics A/S. The 510(k) number is K162037.

When did Eclipse with VEMP receive FDA 510(k) clearance?

Eclipse with VEMP received FDA 510(k) clearance on 2017-03-23, under 510(k) number K162037.

Who is the listed applicant for Eclipse with VEMP?

The FDA 510(k) record lists Interacoustics A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eclipse with VEMP?

The FDA product code for Eclipse with VEMP is GWJ.

Other records listing Interacoustics A/S 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.

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Related Devices (Code: GWJ)

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.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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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