BISX

Index-generating Electroencephalograph Software

ASPECT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Aspect Medical Systems, Inc. with the FDA for Bisx.

Pre-market Notification Details

• Device ID: K040183
• 510k Number: K040183
• Device Name: BISX
• Classification: Index-generating Electroencephalograph Software
• Applicant: ASPECT MEDICAL SYSTEMS, INC. 1775 ROCKIES COURT Lafayette, CO 80026
• Contact: Christine Vozella
• Correspondent: Ned Devine; ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548
• Product Code: OLW
• Subsequent Product Code: OLT
• Subsequent Product Code: OMC
• Subsequent Product Code: ORT
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2004-01-27
• Decision Date: 2004-02-25
• Summary: summary