Cleared Traditional

SUPERSTAND 300

K935123 · Wuestec Medical, Inc. · Radiology
Mar 1996
Decision
881d
Days
Class 1
Risk

About This 510(k) Submission

K935123 is an FDA 510(k) clearance for the SUPERSTAND 300, a Tube Mount, X-ray, Diagnostic (Class I — General Controls, product code IYB), submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on March 27, 1996, 881 days after receiving the submission on October 28, 1993. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1770.

Submission Details

510(k) Number K935123 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1993
Decision Date March 27, 1996
Days to Decision 881 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IYB — Tube Mount, X-ray, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.1770