Cleared Traditional

K925752 - STANDARD
(FDA 510(k) Clearance)

K925752 · Rudolf Riester GmbH & Co. KG · Ear, Nose, Throat
Oct 1993
Decision
329d
Days
Class 1
Risk

K925752 is an FDA 510(k) clearance for the STANDARD. 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 K925752 FDA.gov
FDA Decision Cleared 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

Device Classification

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