Cleared Traditional

K896119 - RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE (FDA 510(k) Clearance)

Nov 1989
Decision
34d
Days
Class 2
Risk

K896119 is an FDA 510(k) clearance for the RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE. This device is classified as a Table, Radiographic, Tilting (Class II - Special Controls, product code IXR).

Submitted by Rms Div. (Addison, US). The FDA issued a Cleared decision on November 27, 1989, 34 days after receiving the submission on October 24, 1989.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K896119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1989
Decision Date November 27, 1989
Days to Decision 34 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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