Cleared Traditional

RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351

K984521 · Richard Wolf Medical Instruments Corp. · Ear, Nose, Throat
Mar 1999
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K984521 is an FDA 510(k) clearance for the RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351, a Laryngostroboscope (Class I — General Controls, product code EQL), submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on March 17, 1999, 86 days after receiving the submission on December 21, 1998. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4750.

Submission Details

510(k) Number K984521 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1998
Decision Date March 17, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EQL — Laryngostroboscope
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4750

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