Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K860438 |
Device Name |
NEWPORT VENTILATOR MODEL E-100 |
Applicant |
NEWPORT MEDICAL INSTRUMENTS, INC. |
P.O. BOX 2600 |
NEWPORT BEACH,
CA
92658
|
|
Applicant Contact |
DOUG DOMURAT |
Correspondent |
NEWPORT MEDICAL INSTRUMENTS, INC. |
P.O. BOX 2600 |
NEWPORT BEACH,
CA
92658
|
|
Correspondent Contact |
DOUG DOMURAT |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 02/04/1986 |
Decision Date | 05/06/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|