BRAINTRACE

Non-normalizing Quantitative Electroencephalograph Software

BRAINSTORMS MONITORING CORP.

The following data is part of a premarket notification filed by Brainstorms Monitoring Corp. with the FDA for Braintrace.

Pre-market Notification Details

• Device ID: K940811
• 510k Number: K940811
• Device Name: BRAINTRACE
• Classification: Non-normalizing Quantitative Electroencephalograph Software
• Applicant: BRAINSTORMS MONITORING CORP. 1776 NORTH MOORPARK RD. Thousand Oaks, CA 91360
• Contact: Diego L Gru
• Correspondent: Diego L Gru; BRAINSTORMS MONITORING CORP. 1776 NORTH MOORPARK RD. Thousand Oaks, CA 91360
• Product Code: OLT
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-02-22
• Decision Date: 1995-05-02