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 a medical device manufactured by Interacoustics A/S. It received FDA 510(k) clearance on 2017-03-23 under approval 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. It is manufactured by Interacoustics A/S. The 510(k) number is K162037.
When was Eclipse with VEMP approved by the FDA?
Eclipse with VEMP received FDA 510(k) clearance on 2017-03-23, under approval number K162037.
What company makes Eclipse with VEMP?
Eclipse with VEMP is manufactured by Interacoustics A/S.
What is the FDA product code for Eclipse with VEMP?
The FDA product code for Eclipse with VEMP is GWJ.
Other Devices by Interacoustics A/S
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K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.
K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
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.