Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K972833 |
Device Name |
E100M VENTILATOR (E100M) |
Applicant |
NEWPORT MEDICAL INSTRUMENTS, INC. |
760 WEST 16TH ST., BLDG. M |
COSTA MESA,
CA
92627
|
|
Applicant Contact |
KARON MORELL |
Correspondent |
NEWPORT MEDICAL INSTRUMENTS, INC. |
760 WEST 16TH ST., BLDG. M |
COSTA MESA,
CA
92627
|
|
Correspondent Contact |
KARON MORELL |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 07/30/1997 |
Decision Date | 09/23/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|