Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K172799 |
Device Name |
Positional Sleep Assessment System (PoSAS) software |
Applicant |
Advanced Brain Monitoring |
2237 Faraday Ave, Suite 100 |
Carlsbad,
CA
92008
|
|
Applicant Contact |
Daniela Soll |
Correspondent |
Advanced Brain Monitoring |
2237 Faraday Ave, Suite 100 |
Carlsbad,
CA
92008
|
|
Correspondent Contact |
Daniela Soll |
Regulation Number | 868.2375
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/18/2017 |
Decision Date | 03/09/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|