Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SMARTEP-ASSR, MODEL M811007

K-Number: K031051 · 2004-02-20

ApplicantIntelligent Hearing Systems
Decision Date2004-02-20
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMARTEP-ASSR, MODEL M811007 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 2004-02-20 under 510(k) number K031051. 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-ASSR, MODEL M811007?

SMARTEP-ASSR, MODEL M811007 is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Intelligent Hearing Systems. The 510(k) number is K031051.

When did SMARTEP-ASSR, MODEL M811007 receive FDA 510(k) clearance?

SMARTEP-ASSR, MODEL M811007 received FDA 510(k) clearance on 2004-02-20, under 510(k) number K031051.

Who is the listed applicant for SMARTEP-ASSR, MODEL M811007?

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-ASSR, MODEL M811007?

The FDA product code for SMARTEP-ASSR, MODEL M811007 is GWJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Intelligent Hearing Systems 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.

K163326SmartEPK090579SMARTSCREENER-PLUS2K073384SMART COUPLER, MODEL M015401K070608SMARTEP, MODEL M010000K063402WICK ELECTRODE, MODEL M019260K061443SMART USBLITE, MODEL M011120

View all 13 devices →

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.

↑