The following data is part of a premarket notification filed by Advanced Brain Monitoring with the FDA for Positional Sleep Assessment System (posas) Software.
| Device ID | K172799 |
| 510k Number | K172799 |
| Device Name: | Positional Sleep Assessment System (PoSAS) Software |
| Classification | Ventilatory Effort Recorder |
| Applicant | Advanced Brain Monitoring 2237 Faraday Ave, Suite 100 Carlsbad, CA 92008 |
| Contact | Daniela Soll |
| Correspondent | Daniela Soll Advanced Brain Monitoring 2237 Faraday Ave, Suite 100 Carlsbad, CA 92008 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-18 |
| Decision Date | 2018-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851113007758 | K172799 | 000 |