Device Classification Name |
Ventilatory Effort Recorder
|
510(k) Number |
K041662 |
Device Name |
APNEA RISK EVALUATION SYSTEM (ARES) |
Applicant |
ADVANCED BRAIN MONITORING, INC. |
2850 PIO PICO DRIVE |
SUITE A |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
DANIEL J LEVENDOWSKI |
Correspondent |
ADVANCED BRAIN MONITORING, INC. |
2850 PIO PICO DRIVE |
SUITE A |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
DANIEL J LEVENDOWSKI |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 06/18/2004 |
Decision Date | 10/14/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|