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FDA 510(k)

OTOSCOPE

K-Number: K902205 · 1990-08-14

ApplicantTruphatek, Ltd.
Decision Date1990-08-14
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Truphatek, Ltd.. It received FDA 510(k) clearance on 1990-08-14 under 510(k) number K902205. 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 OTOSCOPE?

OTOSCOPE is a medical device that received FDA 510(k) clearance on 1990-08-14. The listed applicant is Truphatek, Ltd.. The 510(k) number is K902205.

When did OTOSCOPE receive FDA 510(k) clearance?

OTOSCOPE received FDA 510(k) clearance on 1990-08-14, under 510(k) number K902205.

Who is the listed applicant for OTOSCOPE?

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

What is the FDA product code for OTOSCOPE?

The FDA product code for 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

Other records listing Truphatek, Ltd. 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.

K923227THROAT-A-SCOPEK920272ORIELK883414LARYNGOSCOPE BLADES

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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