Cleared Traditional

GREEN TEC-2100

K955236 · Medtec, Inc. · Radiology
May 1996
Decision
192d
Days
Class 1
Risk

About This 510(k) Submission

K955236 is an FDA 510(k) clearance for the GREEN TEC-2100, a Monitor, Patient Position, Light-beam (Class I — General Controls, product code IWE), submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on May 24, 1996, 192 days after receiving the submission on November 14, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5780.

Submission Details

510(k) Number K955236 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1995
Decision Date May 24, 1996
Days to Decision 192 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IWE — Monitor, Patient Position, Light-beam
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.5780