Cleared Traditional

MODULAR X-RAY BARRIERS

K850814 · Victoreen, Inc. · Radiology
Apr 1985
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K850814 is an FDA 510(k) clearance for the MODULAR X-RAY BARRIERS, a Screen, Leaded, Operator Radiation Protector (Class I — General Controls, product code EAK), submitted by Victoreen, Inc. (Carle Place, US). The FDA issued a Cleared decision on April 10, 1985, 41 days after receiving the submission on February 28, 1985. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number K850814 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 1985
Decision Date April 10, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code EAK — Screen, Leaded, Operator Radiation Protector
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.6500

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