Cleared Traditional

K940721 - CLINIX VP 4 TABLE (FDA 510(k) Clearance)

May 1994
Decision
74d
Days
Class 2
Risk

K940721 is an FDA 510(k) clearance for the CLINIX VP 4 TABLE. This device is classified as a Table, Radiographic, Tilting (Class II - Special Controls, product code IXR).

Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on May 3, 1994, 74 days after receiving the submission on February 18, 1994.

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

Submission Details

510(k) Number K940721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1994
Decision Date May 03, 1994
Days to Decision 74 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

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