Cleared Traditional

MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION

K940284 · Meddev International Corp. · General Hospital

Feb 1994

Decision

55d

Days

Class 1

Risk

About This 510(k) Submission

K940284 is an FDA 510(k) clearance for the MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION, 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 February 28, 1994, 55 days after receiving the submission on January 4, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6320.

Submission Details

510(k) Number	K940284 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 04, 1994
Decision Date	February 28, 1994
Days to Decision	55 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement