Cleared Traditional

K925753 - UNI III
(FDA 510(k) Clearance)

K925753 · Rudolf Riester GmbH & Co. KG · Ear, Nose, Throat

Oct 1993

Decision

329d

Days

Class 1

Risk

K925753 is an FDA 510(k) clearance for the UNI III. This device is classified as a Otoscope (Class I — General Controls, product code ERA).

Submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on October 8, 1993, 329 days after receiving the submission on November 13, 1992.

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

Submission Details

510(k) Number	K925753 FDA.gov
FDA Decision	Cleared Substantially Equivalent — Traditional 510(k) (SESE)
Date Received	November 13, 1992
Decision Date	October 08, 1993
Days to Decision	329 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement