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FDA 510(k)

OPTIEAR

K-Number: K920322 · 1992-04-23

ApplicantNankivell Industries, Inc.
Decision Date1992-04-23
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OPTIEAR is the device name listed in this FDA 510(k) record. The listed applicant is Nankivell Industries, Inc.. It received FDA 510(k) clearance on 1992-04-23 under 510(k) number K920322. 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 OPTIEAR?

OPTIEAR is a medical device that received FDA 510(k) clearance on 1992-04-23. The listed applicant is Nankivell Industries, Inc.. The 510(k) number is K920322.

When did OPTIEAR receive FDA 510(k) clearance?

OPTIEAR received FDA 510(k) clearance on 1992-04-23, under 510(k) number K920322.

Who is the listed applicant for OPTIEAR?

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

What is the FDA product code for OPTIEAR?

The FDA product code for OPTIEAR 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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