ZIEHM VISION

Interventional Fluoroscopic X-ray System

ZIEHM INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Ziehm Vision.

Pre-market Notification Details

• Device ID: K011292
• 510k Number: K011292
• Device Name: ZIEHM VISION
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: ZIEHM INTERNATIONAL, INC. 4181 LATHAM ST. Riverside, CA 92501
• Contact: Lanell Samaniego
• Correspondent: Lanell Samaniego; ZIEHM INTERNATIONAL, INC. 4181 LATHAM ST. Riverside, CA 92501
• Product Code: OWB
• Subsequent Product Code: JAA
• Subsequent Product Code: OXO
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-04-30
• Decision Date: 2001-06-20