The following data is part of a premarket notification filed by Advanced Brain Monitoring, Inc. with the FDA for Sleep Profiler.
| Device ID | K153412 |
| 510k Number | K153412 |
| Device Name: | Sleep Profiler |
| Classification | Automatic Event Detection Software For Polysomnograph With 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 W324 S3649 COUNTY ROAD E Dousman, WI 53118 |
| Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-25 |
| Decision Date | 2016-03-14 |
| Summary: | summary |