LANTOS 3D EAR SCANNER— 510(k) K121326

Substantially Equivalent

Lantos Technologies

FDA 510(k) clearance K121326 for LANTOS 3D EAR SCANNER, Substantially Equivalent on 2013-01-25. Applicant: Lantos Technologies. Device class: 1.

Clearance details

Applicant: Lantos Technologies
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 2012-05-02
Decision date: 2013-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South West Ranches, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ERA

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K945264 — OPTUS OTOSCOPES1996-02-02
K955043 — WELCH ALLYN BI-OTOSCOPE1995-11-14
K952578 — WELCH ALLY OTOSCOPE1995-07-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.