NEUROMAP

Electrode, Depth

RADIONICS, INC.

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

Pre-market Notification Details

• Device ID: K981820
• 510k Number: K981820
• Device Name: NEUROMAP
• Classification: Electrode, Depth
• Applicant: RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516
• Contact: Jeffrey R Mannion
• Correspondent: Jeffrey R Mannion; RADIONICS, INC. 22 TERRY AVE. Burlington, MA 01803 -2516
• Product Code: GZL
• CFR Regulation Number: 882.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-05-22
• Decision Date: 1998-11-20