C-QUEST

Interventional Fluoroscopic X-ray System

WUESTEC MEDICAL, INC.

The following data is part of a premarket notification filed by Wuestec Medical, Inc. with the FDA for C-quest.

Pre-market Notification Details

• Device ID: K992103
• 510k Number: K992103
• Device Name: C-QUEST
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: WUESTEC MEDICAL, INC. 5600 COMMERCE BLVD., EAST Mobile, AL 36619 -0037
• Contact: Brenda Davis
• Correspondent: Brenda Davis; WUESTEC MEDICAL, INC. 5600 COMMERCE BLVD., EAST Mobile, AL 36619 -0037
• 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: 1999-06-22
• Decision Date: 1999-09-01