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)

OPTUS OTOSCOPES

K-Number: K945264 · 1996-02-02

ApplicantOptus, Inc.
Decision Date1996-02-02
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OPTUS OTOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Optus, Inc.. It received FDA 510(k) clearance on 1996-02-02 under 510(k) number K945264. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTUS OTOSCOPES?

OPTUS OTOSCOPES is a medical device that received FDA 510(k) clearance on 1996-02-02. The listed applicant is Optus, Inc.. The 510(k) number is K945264.

When did OPTUS OTOSCOPES receive FDA 510(k) clearance?

OPTUS OTOSCOPES received FDA 510(k) clearance on 1996-02-02, under 510(k) number K945264.

Who is the listed applicant for OPTUS OTOSCOPES?

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

What is the FDA product code for OPTUS OTOSCOPES?

The FDA product code for OPTUS OTOSCOPES is ERA.

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 Optus, Inc. 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.

K953913OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIESK945268OPTUS BRONCHOSCOPESK945265OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPESK945262OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPESK945267OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPESK945266OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES

View all 10 devices →

Related Devices (Code: ERA)

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.

K123821AIO HD OTOSCOPEBlue FocusK121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, Inc.K950913PERFECT, ENT SET, PRAKTIKANT, DE LUXERudolf Riester GmbH & Co. KG

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.

↑