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).
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 |