Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K901785 |
Device Name |
NEWPORT WAVE VENTILATOR MODEL E200 |
Applicant |
NEWPORT MEDICAL INSTRUMENTS, INC. |
P.O. BOX 2600 |
NEWPORT BEACH,
CA
92658
|
|
Applicant Contact |
MILLER, RRT |
Correspondent |
NEWPORT MEDICAL INSTRUMENTS, INC. |
P.O. BOX 2600 |
NEWPORT BEACH,
CA
92658
|
|
Correspondent Contact |
MILLER, RRT |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 04/18/1990 |
Decision Date | 08/10/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|