NC-STAT

Device, Nerve Conduction Velocity Measurement

NEUROMETRIX, INC.

The following data is part of a premarket notification filed by Neurometrix, Inc. with the FDA for Nc-stat.

Pre-market Notification Details

• Device ID: K060584
• 510k Number: K060584
• Device Name: NC-STAT
• Classification: Device, Nerve Conduction Velocity Measurement
• Applicant: NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451
• Contact: Rainer N Maas
• Correspondent: Rainer N Maas; NEUROMETRIX, INC. 62 FOURTH AVE. Waltham, MA 02451
• Product Code: JXE
• CFR Regulation Number: 882.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-03-07
• Decision Date: 2006-07-31
• Summary: summary