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FDA 510(k)

LANTOS 3D EAR SCANNER

K-Number: K121326 · 2013-01-25

ApplicantLantos Technologies
Decision Date2013-01-25
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LANTOS 3D EAR SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Lantos Technologies. It received FDA 510(k) clearance on 2013-01-25 under 510(k) number K121326. 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 LANTOS 3D EAR SCANNER?

LANTOS 3D EAR SCANNER is a medical device that received FDA 510(k) clearance on 2013-01-25. The listed applicant is Lantos Technologies. The 510(k) number is K121326.

When did LANTOS 3D EAR SCANNER receive FDA 510(k) clearance?

LANTOS 3D EAR SCANNER received FDA 510(k) clearance on 2013-01-25, under 510(k) number K121326.

Who is the listed applicant for LANTOS 3D EAR SCANNER?

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

What is the FDA product code for LANTOS 3D EAR SCANNER?

The FDA product code for LANTOS 3D EAR SCANNER 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 FocusK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, 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.

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