Cleared Traditional

RI-MINI

K932503 · Rudolf Riester GmbH & Co. KG · Ear, Nose, Throat
Oct 1993
Decision
140d
Days
Class 1
Risk

About This 510(k) Submission

K932503 is an FDA 510(k) clearance for the RI-MINI, 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, 140 days after receiving the submission on May 21, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4770.

Submission Details

510(k) Number K932503 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 1993
Decision Date October 08, 1993
Days to Decision 140 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