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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 the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Hearing Systems. It received FDA 510(k) clearance on 2017-09-29 under 510(k) 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. The listed applicant is Intelligent Hearing Systems. The 510(k) number is K163326.

When did SmartEP receive FDA 510(k) clearance?

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

Who is the listed applicant for SmartEP?

The FDA 510(k) record lists Intelligent Hearing Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartEP?

The FDA product code for SmartEP is GWJ.

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 StadlerK162037Eclipse with VEMPInteracoustics A/S

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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