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: K003508
• 510k Number: K003508
• Device Name: NC-STAT
• Classification: Device, Nerve Conduction Velocity Measurement
• Applicant: NEUROMETRIX, INC. 49 PLAIN ST. North Attleboro, MA 02760
• Contact: James R Veale
• Correspondent: James R Veale; NEUROMETRIX, INC. 49 PLAIN ST. North Attleboro, MA 02760
• Product Code: JXE
• CFR Regulation Number: 882.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-11-14
• Decision Date: 2001-01-17