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FDA 510(k)

EARBEAR OTOSCOPE

K-Number: K915537 · 1992-01-24

ApplicantEarbear Co.
Decision Date1992-01-24
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EARBEAR OTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Earbear Co.. It received FDA 510(k) clearance on 1992-01-24 under 510(k) number K915537. 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 EARBEAR OTOSCOPE?

EARBEAR OTOSCOPE is a medical device that received FDA 510(k) clearance on 1992-01-24. The listed applicant is Earbear Co.. The 510(k) number is K915537.

When did EARBEAR OTOSCOPE receive FDA 510(k) clearance?

EARBEAR OTOSCOPE received FDA 510(k) clearance on 1992-01-24, under 510(k) number K915537.

Who is the listed applicant for EARBEAR OTOSCOPE?

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

What is the FDA product code for EARBEAR OTOSCOPE?

The FDA product code for EARBEAR OTOSCOPE 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

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.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, 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.

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