Cleared Traditional

K896665 - EXT-600 TABLE, RADIOGRAPHIC, ELEVATING
(FDA 510(k) Clearance)

Jan 1990
Decision
56d
Days
Class 2
Risk

K896665 is an FDA 510(k) clearance for the EXT-600 TABLE, RADIOGRAPHIC, ELEVATING. This device is classified as a Table, Radiographic, Non-tilting, Powered (Class II - Special Controls, product code IZZ).

Submitted by Rms Div. (Addison, US). The FDA issued a Cleared decision on January 22, 1990, 56 days after receiving the submission on November 27, 1989.

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

Submission Details

510(k) Number K896665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1989
Decision Date January 22, 1990
Days to Decision 56 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code IZZ — Table, Radiographic, Non-tilting, Powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 892.1980

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