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)

SMARTTROAE

K-Number: K023859 · 2003-01-08

ApplicantIntelligent Hearing Systems
Decision Date2003-01-08
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SMARTTROAE 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 2003-01-08 under 510(k) number K023859. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTTROAE?

SMARTTROAE is a medical device that received FDA 510(k) clearance on 2003-01-08. The listed applicant is Intelligent Hearing Systems. The 510(k) number is K023859.

When did SMARTTROAE receive FDA 510(k) clearance?

SMARTTROAE received FDA 510(k) clearance on 2003-01-08, under 510(k) number K023859.

Who is the listed applicant for SMARTTROAE?

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 SMARTTROAE?

The FDA product code for SMARTTROAE is EWO.

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: EWO)

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.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

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.

↑