Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K121891 |
Device Name |
NEWPORT AURA VENTILATOR |
Applicant |
NEWPORT MEDICAL INSTRUMENTS, INC. |
1620 SUNFLOWER AVE. |
costa mesa,
CA
92626
|
|
Applicant Contact |
tom colonna |
Correspondent |
NEWPORT MEDICAL INSTRUMENTS, INC. |
1620 SUNFLOWER AVE. |
costa mesa,
CA
92626
|
|
Correspondent Contact |
tom colonna |
Regulation Number | 868.5895
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/29/2012 |
Decision Date | 11/09/2012 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|