X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)

Reduced- Montage Standard Electroencephalograph

ADVANCED BRAIN MONITORING, INC.

The following data is part of a premarket notification filed by Advanced Brain Monitoring, Inc. with the FDA for X8 System - Sleep Profiler (sp40), X8 System - Sleep Profiler Psg2 (sp29), X8 System - Stat X8 (xs29).

Pre-market Notification Details

• Device ID: K152040
• 510k Number: K152040
• Device Name: X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)
• Classification: Reduced- Montage Standard Electroencephalograph
• Applicant: ADVANCED BRAIN MONITORING, INC. 2237 FARADAY AVENUE, SUITE 100 Carlsbad, CA 92008
• Contact: Daniel J. Levendowski
• Correspondent: Adrienne Lenz; PATHWAY REGULATORY CONSULTING, LLC W324S3649 COUNTY ROAD E Dousman, WI 53118
• Product Code: OMC
• CFR Regulation Number: 882.1400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-07-22
• Decision Date: 2015-10-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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