Cleared Traditional

K945264 - OPTUS OTOSCOPES
(FDA 510(k) Clearance)

K945264 · Optus, Inc. · Ear, Nose, Throat device

Feb 1996

Decision

462d

Days

Class 1

Risk

K945264 is an FDA 510(k) clearance for the OPTUS OTOSCOPES. This device is classified as a Otoscope (Class I - General Controls, product code ERA).

Submitted by Optus, Inc. (Denver, US). The FDA issued a Cleared decision on February 2, 1996, 462 days after receiving the submission on October 28, 1994.

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

Submission Details

510(k) Number	K945264 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 28, 1994
Decision Date	February 02, 1996
Days to Decision	462 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement