QUIK-CAP

Electrode, Cutaneous

NEUROSCAN

The following data is part of a premarket notification filed by Neuroscan with the FDA for Quik-cap.

Pre-market Notification Details

• Device ID: K000865
• 510k Number: K000865
• Device Name: QUIK-CAP
• Classification: Electrode, Cutaneous
• Applicant: NEUROSCAN 45150 BUSINESS CT., SUITE 100 Sterling, VA 20166
• Contact: David B Jones
• Correspondent: David B Jones; NEUROSCAN 45150 BUSINESS CT., SUITE 100 Sterling, VA 20166
• Product Code: GXY
• CFR Regulation Number: 882.1320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-03-17
• Decision Date: 2000-04-18