Device Classification Name |
apparatus, nitric oxide, backup delivery
|
510(k) Number |
K122689 |
Device Name |
INOBLENDER |
Applicant |
INO THERAPEUTICS |
2902 DAIRY DRIVE |
MADISON,
WI
53718
|
|
Applicant Contact |
ROBERT BOVY |
Correspondent |
INO THERAPEUTICS |
2902 DAIRY DRIVE |
MADISON,
WI
53718
|
|
Correspondent Contact |
ROBERT BOVY |
Regulation Number | 868.5165
|
Classification Product Code |
|
Date Received | 09/04/2012 |
Decision Date | 11/07/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|