Cleared Traditional

MED-TEC STRING RETICLE TRAY

K951601 · Medtec, Inc. · Radiology
May 1995
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K951601 is an FDA 510(k) clearance for the MED-TEC STRING RETICLE TRAY, 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 11, 1995, 34 days after receiving the submission on April 7, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5780.

Submission Details

510(k) Number K951601 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1995
Decision Date May 11, 1995
Days to Decision 34 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