Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K002951 |
Device Name |
MAGELLAN VENTILATOR |
Applicant |
OCEANIC MEDICAL PRODUCTS, INC. |
8005 SHANNON INDUSTRIAL PARK |
LN. |
ATCHISON,
KS
66002
|
|
Applicant Contact |
WILLIAM M GATES |
Correspondent |
OCEANIC MEDICAL PRODUCTS, INC. |
8005 SHANNON INDUSTRIAL PARK |
LN. |
ATCHISON,
KS
66002
|
|
Correspondent Contact |
WILLIAM M GATES |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 09/21/2000 |
Decision Date | 12/08/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|