Cleared Traditional

TEC-2110 GREEN LASER MODEL MT-HNG

K950293 · Medtec, Inc. · Radiology
Aug 1995
Decision
205d
Days
Class 1
Risk

About This 510(k) Submission

K950293 is an FDA 510(k) clearance for the TEC-2110 GREEN LASER MODEL MT-HNG, 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 August 18, 1995, 205 days after receiving the submission on January 25, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5780.

Submission Details

510(k) Number K950293 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1995
Decision Date August 18, 1995
Days to Decision 205 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