Cleared Traditional

K123821 - AIO HD OTOSCOPE
(FDA 510(k) Clearance)

K123821 · Blue Focus · Ear, Nose, Throat device

May 2013

Decision

156d

Days

Class 1

Risk

K123821 is an FDA 510(k) clearance for the AIO HD OTOSCOPE. This device is classified as a Otoscope (Class I - General Controls, product code ERA).

Submitted by Blue Focus (Lawrenceville, US). The FDA issued a Cleared decision on May 17, 2013, 156 days after receiving the submission on December 12, 2012.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4770.

Submission Details

510(k) Number	K123821 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 12, 2012
Decision Date	May 17, 2013
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF