OPTUS OTOSCOPES— 510(k) K945264

Substantially Equivalent

Optus, Inc.

FDA 510(k) clearance K945264 for OPTUS OTOSCOPES, Substantially Equivalent on 1996-02-02. Applicant: Optus, Inc.. Device class: 1.

Clearance details

Applicant: Optus, Inc.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1994-10-28
Decision date: 1996-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, 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
K110326 — OSRAM ITOS2011-10-27
K955043 — WELCH ALLYN BI-OTOSCOPE1995-11-14
K952578 — WELCH ALLY OTOSCOPE1995-07-10

More clearances from Optus, Inc.

K953913 — OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES1996-01-22
K945268 — OPTUS BRONCHOSCOPES1995-12-21
K945265 — OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES1995-09-12
K945262 — OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES1995-05-26
K945267 — OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES1995-05-23

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