AIO HD OTOSCOPE— 510(k) K123821

Substantially Equivalent

Blue Focus

FDA 510(k) clearance K123821 for AIO HD OTOSCOPE, Substantially Equivalent on 2013-05-17. Applicant: Blue Focus. Device class: 1.

Clearance details

Applicant: Blue Focus
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 2012-12-12
Decision date: 2013-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrenceville, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ERA

K121326 — LANTOS 3D EAR SCANNER2013-01-25
K110326 — OSRAM ITOS2011-10-27
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.