Cleared Traditional

620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB

K905265 · Tri W-G, Inc. · Radiology
Jan 1991
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K905265 is an FDA 510(k) clearance for the 620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB, a Table, Radiographic, Tilting (Class II — Special Controls, product code IXR), submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on January 23, 1991, 61 days after receiving the submission on November 23, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K905265 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 1990
Decision Date January 23, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IXR — Table, Radiographic, Tilting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980

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