GENESIS II

System, X-ray, Fluoroscopic, Image-intensified

DORNIER MEDTECH AMERICA, INC.

The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Genesis Ii.

Pre-market Notification Details

• Device ID: K133434
• 510k Number: K133434
• Device Name: GENESIS II
• Classification: System, X-ray, Fluoroscopic, Image-intensified
• Applicant: DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144
• Contact: John Hoffer
• Correspondent: John Hoffer; DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144
• Product Code: JAA
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-11-08
• Decision Date: 2014-11-26
• Summary: summary