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)

EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE

K-Number: K090406 · 2009-07-22

ApplicantInteracoustics AS
Decision Date2009-07-22
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Interacoustics AS. It received FDA 510(k) clearance on 2009-07-22 under 510(k) number K090406. 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 EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE?

EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE is a medical device that received FDA 510(k) clearance on 2009-07-22. The listed applicant is Interacoustics AS. The 510(k) number is K090406.

When did EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE receive FDA 510(k) clearance?

EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE received FDA 510(k) clearance on 2009-07-22, under 510(k) number K090406.

Who is the listed applicant for EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE?

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

What is the FDA product code for EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE?

The FDA product code for EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE 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 Interacoustics AS 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.

K083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEK052562ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.K043219AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS

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.

↑