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FDA 510(k)

SMARTSCREENER-PLUS2

K-Number: K090579 · 2009-07-07

ApplicantIntelligent Hearing Systems
Decision Date2009-07-07
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMARTSCREENER-PLUS2 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 2009-07-07 under 510(k) number K090579. 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 SMARTSCREENER-PLUS2?

SMARTSCREENER-PLUS2 is a medical device that received FDA 510(k) clearance on 2009-07-07. The listed applicant is Intelligent Hearing Systems. The 510(k) number is K090579.

When did SMARTSCREENER-PLUS2 receive FDA 510(k) clearance?

SMARTSCREENER-PLUS2 received FDA 510(k) clearance on 2009-07-07, under 510(k) number K090579.

Who is the listed applicant for SMARTSCREENER-PLUS2?

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 SMARTSCREENER-PLUS2?

The FDA product code for SMARTSCREENER-PLUS2 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.

K163326SmartEPK073384SMART COUPLER, MODEL M015401K070608SMARTEP, MODEL M010000K063402WICK ELECTRODE, MODEL M019260K061443SMART USBLITE, MODEL M011120K052060OPTI-AMP DC-POWERED

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.

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