MODEL 500-6 RADIATION THERAPY IONIZATION CHAMBER

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

VICTOREEN, INC.

The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Model 500-6 Radiation Therapy Ionization Chamber.

Pre-market Notification Details

• Device ID: K932342
• 510k Number: K932342
• Device Name: MODEL 500-6 RADIATION THERAPY IONIZATION CHAMBER
• Classification: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
• Applicant: VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304
• Contact: Robert Kobistek
• Correspondent: Robert Kobistek; VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304
• Product Code: LNN
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-05-14
• Decision Date: 1993-12-13