NUMALINK

System, Image Processing, Radiological

NUMA, INC.

The following data is part of a premarket notification filed by Numa, Inc. with the FDA for Numalink.

Pre-market Notification Details

• Device ID: K002724
• 510k Number: K002724
• Device Name: NUMALINK
• Classification: System, Image Processing, Radiological
• Applicant: NUMA, INC. 10 NORTHERN BLVD., UNIT 12 Amherst, NH 03031
• Contact: Larry Smith
• Correspondent: Larry Smith; NUMA, INC. 10 NORTHERN BLVD., UNIT 12 Amherst, NH 03031
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-08-31
• Decision Date: 2000-11-17