The following data is part of a premarket notification filed by Advanced Brain Monitoring, Inc. with the FDA for Sleep Profiler.
| Device ID | K130007 |
| 510k Number | K130007 |
| Device Name: | SLEEP PROFILER |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | ADVANCED BRAIN MONITORING, INC. W324 S3649 COUNTY RD E Dousman, WI 53118 |
| Contact | Adrienne Lenz |
| Correspondent | Adrienne Lenz ADVANCED BRAIN MONITORING, INC. W324 S3649 COUNTY RD 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 | 2013-01-02 |
| Decision Date | 2013-04-17 |
| Summary: | summary |