Cleared Traditional

CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE

K932259 · Clarus Medical Systems, Inc. · Ear, Nose, Throat

Dec 1993

Decision

239d

Days

Class 1

Risk

About This 510(k) Submission

K932259 is an FDA 510(k) clearance for the CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE, a Otoscope (Class I — General Controls, product code ERA), submitted by Clarus Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 15, 1993, 239 days after receiving the submission on April 20, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4770.

Submission Details

510(k) Number	K932259 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 20, 1993
Decision Date	December 15, 1993
Days to Decision	239 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF