Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K030515 |
Device Name |
HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS |
Applicant |
HANS RUDOLPH, INC. |
7200 WYANDOTTE |
KANSAS CITY,
MO
64114
|
|
Applicant Contact |
KEVIN RUDOLPH |
Correspondent |
HANS RUDOLPH, INC. |
7200 WYANDOTTE |
KANSAS CITY,
MO
64114
|
|
Correspondent Contact |
KEVIN RUDOLPH |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 02/19/2003 |
Decision Date | 05/02/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|