NEUROTRAC

Full-montage Standard Electroencephalograph

INTERSPEC, INC.

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

Pre-market Notification Details

• Device ID: K823116
• 510k Number: K823116
• Device Name: NEUROTRAC
• Classification: Full-montage Standard Electroencephalograph
• Applicant: INTERSPEC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GWQ
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-10-21
• Decision Date: 1982-12-07