Cleared Traditional

MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT

K931197 · Meddev International Corp. · General Hospital

Sep 1993

Decision

198d

Days

Class 1

Risk

About This 510(k) Submission

K931197 is an FDA 510(k) clearance for the MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT, a Device, Medical Examination, Ac Powered (Class I — General Controls, product code KZF), submitted by Meddev International Corp. (Los Altos, US). The FDA issued a Cleared decision on September 23, 1993, 198 days after receiving the submission on March 9, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6320.

Submission Details

510(k) Number	K931197 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 1993
Decision Date	September 23, 1993
Days to Decision	198 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement