OSRAM ITOS— 510(k) K110326

Substantially Equivalent

Osram Sylvania, Inc.

FDA 510(k) clearance K110326 for OSRAM ITOS, Substantially Equivalent on 2011-10-27. Applicant: Osram Sylvania, Inc.. Device class: 1.

Clearance details

Applicant: Osram Sylvania, Inc.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 2011-02-03
Decision date: 2011-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ERA

K123821 — AIO HD OTOSCOPE2013-05-17
K121326 — LANTOS 3D EAR SCANNER2013-01-25
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.