Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K905404 |
Device Name |
MEDTRONIC SULLIVAN NASAL CPAP SYSTEM |
Applicant |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. N.E. |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
LINDA S ALEXANDER |
Correspondent |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. N.E. |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
LINDA S ALEXANDER |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 12/03/1990 |
Decision Date | 05/13/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|