Cleared Traditional

RADIOLOGICAL PROTECTIVE EYE SHIELD

K920540 · Burkhart Roentgen Intl., Inc. · Radiology
May 1992
Decision
113d
Days
Class 1
Risk

About This 510(k) Submission

K920540 is an FDA 510(k) clearance for the RADIOLOGICAL PROTECTIVE EYE SHIELD, a Shield, Eye, Radiological (Class I — General Controls, product code IWS), submitted by Burkhart Roentgen Intl., Inc. (Pinellas Park, US). The FDA issued a Cleared decision on May 28, 1992, 113 days after receiving the submission on February 5, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.6500.

Submission Details

510(k) Number K920540 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 1992
Decision Date May 28, 1992
Days to Decision 113 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IWS — Shield, Eye, Radiological
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.6500