Cleared Traditional

ED CORP RADIATION SCREEN

K944445 · Med Corp. · Radiology

May 1995

Decision

241d

Days

Class 1

Risk

About This 510(k) Submission

K944445 is an FDA 510(k) clearance for the ED CORP RADIATION SCREEN, a Screen, Leaded, Operator Radiation Protector (Class I — General Controls, product code EAK), submitted by Med Corp. (Ames, US). The FDA issued a Cleared decision on May 11, 1995, 241 days after receiving the submission on September 12, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number	K944445 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 1994
Decision Date	May 11, 1995
Days to Decision	241 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement