COMPAS

System, X-ray, Angiographic

GENERAL ELECTRIC CO.

The following data is part of a premarket notification filed by General Electric Co. with the FDA for Compas.

Pre-market Notification Details

• Device ID: K945483
• 510k Number: K945483
• Device Name: COMPAS
• Classification: System, X-ray, Angiographic
• Applicant: GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201
• Contact: Larry A Kroger
• Correspondent: Larry A Kroger; GENERAL ELECTRIC CO. P.O. BOX 414 Milwaukee, WI 53201
• Product Code: IZI
• CFR Regulation Number: 892.1600 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-08
• Decision Date: 1994-12-09