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)

OTOFLEX 100 TYE 1012

K-Number: K033645 · 2004-03-31

ApplicantGn Otometrics A/S
Decision Date2004-03-31
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOFLEX 100 TYE 1012 is the device name listed in this FDA 510(k) record. The listed applicant is Gn Otometrics A/S. It received FDA 510(k) clearance on 2004-03-31 under 510(k) number K033645. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTOFLEX 100 TYE 1012?

OTOFLEX 100 TYE 1012 is a medical device that received FDA 510(k) clearance on 2004-03-31. The listed applicant is Gn Otometrics A/S. The 510(k) number is K033645.

When did OTOFLEX 100 TYE 1012 receive FDA 510(k) clearance?

OTOFLEX 100 TYE 1012 received FDA 510(k) clearance on 2004-03-31, under 510(k) number K033645.

Who is the listed applicant for OTOFLEX 100 TYE 1012?

The FDA 510(k) record lists Gn Otometrics A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OTOFLEX 100 TYE 1012?

The FDA product code for OTOFLEX 100 TYE 1012 is ETY.

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 Gn Otometrics A/S 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.

K110286GN OTOMETRICS TYPE 1053 FREEFITK083399ICS CHARTR EP 200K061791FOCUS VNG/ENG TYPE 1068K061104SPEECHLINK 100 TYPE 1053

Related Devices (Code: ETY)

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.

K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.K162210touchTympMaico Diagnostics GmbHK161707Madsen ZodiacGn OtometricsK121847TITANInteracoustics A/SK083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEInteracoustics AS

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.

↑