Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K844350 |
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 | 11/09/1984 |
Decision Date | 12/27/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|