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FDA 510(k)

OTOVIEW TELESCOPIC OTOSCOPES

K-Number: K943721 · 1994-11-18

ApplicantSmith & Nephew, Inc.
Decision Date1994-11-18
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOVIEW TELESCOPIC OTOSCOPES is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1994-11-18 under 510(k) number K943721. 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 OTOVIEW TELESCOPIC OTOSCOPES?

OTOVIEW TELESCOPIC OTOSCOPES is a medical device that received FDA 510(k) clearance on 1994-11-18. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K943721.

When did OTOVIEW TELESCOPIC OTOSCOPES receive FDA 510(k) clearance?

OTOVIEW TELESCOPIC OTOSCOPES received FDA 510(k) clearance on 1994-11-18, under 510(k) number K943721.

Who is the listed applicant for OTOVIEW TELESCOPIC OTOSCOPES?

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

What is the FDA product code for OTOVIEW TELESCOPIC OTOSCOPES?

The FDA product code for OTOVIEW TELESCOPIC OTOSCOPES is ERA.

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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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