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FDA 510(k)

SmartEP

K-Number: K163326 · 2017-09-29

ApplicantIntelligent Hearing Systems
Decision Date2017-09-29
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SmartEP is a medical device manufactured by Intelligent Hearing Systems. It received FDA 510(k) clearance on 2017-09-29 under approval number K163326. 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 SmartEP?

SmartEP is a medical device that received FDA 510(k) clearance on 2017-09-29. It is manufactured by Intelligent Hearing Systems. The 510(k) number is K163326.

When was SmartEP approved by the FDA?

SmartEP received FDA 510(k) clearance on 2017-09-29, under approval number K163326.

What company makes SmartEP?

SmartEP is manufactured by Intelligent Hearing Systems.

What is the FDA product code for SmartEP?

The FDA product code for SmartEP is GWJ.

Related Devices (Code: GWJ)

K162037Eclipse with VEMPInteracoustics A/S K193033GSI Audera ProGrason Stadler K211147ALGO 7iPath Medical GmbH K220139QScreenPath Medical GmbH 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.

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