Cleared Traditional

K110326 - OSRAM ITOS
(FDA 510(k) Clearance)

K110326 · Osram Sylvania, Inc. · Ear, Nose, Throat
Oct 2011
Decision
266d
Days
Class 1
Risk

K110326 is an FDA 510(k) clearance for the OSRAM ITOS. This device is classified as a Otoscope (Class I — General Controls, product code ERA).

Submitted by Osram Sylvania, Inc. (Rockville, US). The FDA issued a Cleared decision on October 27, 2011, 266 days after receiving the submission on February 3, 2011.

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

Submission Details

510(k) Number K110326 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2011
Decision Date October 27, 2011
Days to Decision 266 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ERA — Otoscope
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4770