Cleared Traditional

DUAL RADIATION TARGETING SYSTEM DRTS DRAPE

K973162 · Hogan & Hartson · General Hospital
Nov 1997
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K973162 is an FDA 510(k) clearance for the DUAL RADIATION TARGETING SYSTEM DRTS DRAPE, a Monitor, Patient Position, Light-beam (Class I — General Controls, product code IWE), submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on November 20, 1997, 90 days after receiving the submission on August 22, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 892.5780.

Submission Details

510(k) Number K973162 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1997
Decision Date November 20, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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