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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851113007741 | K152040 | 000 |
| 00850015266607 | K152040 | 000 |
| 00850015266591 | K152040 | 000 |
| 00850015266676 | K152040 | 000 |
| 00850015266829 | K152040 | 000 |
| 00850015266812 | K152040 | 000 |
| 00850015266850 | K152040 | 000 |
| 00850015266669 | K152040 | 000 |
| 00850015266256 | K152040 | 000 |
| 00850015266867 | K152040 | 000 |
| 00850015266874 | K152040 | 000 |
| 00850015266959 | K152040 | 000 |
| 00850015266942 | K152040 | 000 |
| 00850015266997 | K152040 | 000 |
| 00850015266980 | K152040 | 000 |
| 00850015266973 | K152040 | 000 |
| 00850015266225 | K152040 | 000 |
| 00850015266539 | K152040 | 000 |
| 00850015266546 | K152040 | 000 |
| 00851113007321 | K152040 | 000 |
| 00851113007314 | K152040 | 000 |
| 00851113007307 | K152040 | 000 |
| 00851113007154 | K152040 | 000 |
| 00851113007253 | K152040 | 000 |
| 00851113007246 | K152040 | 000 |
| 00851113007239 | K152040 | 000 |
| 10851113007229 | K152040 | 000 |
| 20851113007219 | K152040 | 000 |
| 00851113007192 | K152040 | 000 |
| 00851113007185 | K152040 | 000 |
| 00851113007178 | K152040 | 000 |
| 00851113007949 | K152040 | 000 |
| 00850015266201 | K152040 | 000 |
| 00850015266522 | K152040 | 000 |
| 00850015266966 | K152040 | 000 |