Cleared Traditional

CARBON FIBER COUCH INSERT

K950068 · Medtec, Inc. · Radiology
Apr 1995
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K950068 is an FDA 510(k) clearance for the CARBON FIBER COUCH INSERT, a Table, Radiologic (Class II — Special Controls, product code KXJ), submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on April 6, 1995, 87 days after receiving the submission on January 9, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K950068 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 1995
Decision Date April 06, 1995
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

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