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FDA 510(k)

INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)

K-Number: K070696 · 2007-06-29

ApplicantInteracoustics A/S
Decision Date2007-06-29
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) 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 2007-06-29 under 510(k) number K070696. 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 INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)?

INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Interacoustics A/S. The 510(k) number is K070696.

When did INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) receive FDA 510(k) clearance?

INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) received FDA 510(k) clearance on 2007-06-29, under 510(k) number K070696.

Who is the listed applicant for INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)?

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 INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)?

The FDA product code for INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) is GWJ.

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Other records listing Interacoustics A/S as applicant

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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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