Cleared Traditional

K811969 - DUAL PEDESTAL TABLE (FDA 510(k) Clearance)

Aug 1981
Decision
34d
Days
Class 2
Risk

K811969 is an FDA 510(k) clearance for the DUAL PEDESTAL TABLE. This device is classified as a Table, Radiologic (Class II - Special Controls, product code KXJ).

Submitted by Philips Medical Systems (Cleveland), Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981, 34 days after receiving the submission on July 10, 1981.

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

Submission Details

510(k) Number K811969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1981
Decision Date August 13, 1981
Days to Decision 34 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code KXJ — Table, Radiologic
Device Class Class II - Special Controls
CFR Regulation 21 CFR 892.1980