Device Classification Name |
apparatus, nitric oxide, backup delivery
|
510(k) Number |
K011874 |
Device Name |
FADASIS MEDICAL FM-1 NO BLENDER |
Applicant |
FADASIS MEDICAL, INC. |
7601-B MURPHY DR. |
MIDDLETOWN,
WI
53562
|
|
Applicant Contact |
RAYMOND RIDDLE |
Correspondent |
FADASIS MEDICAL, INC. |
7601-B MURPHY DR. |
MIDDLETOWN,
WI
53562
|
|
Correspondent Contact |
RAYMOND RIDDLE |
Regulation Number | 868.5165
|
Classification Product Code |
|
Date Received | 06/15/2001 |
Decision Date | 07/20/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|