Device Classification Name |
Apparatus, Nitric Oxide Delivery
|
510(k) Number |
K121021 |
Device Name |
INOMAX DS (DELIVERY SYSTEM) |
Applicant |
INO THERAPEUTICS |
2902 DAIRY DRIVE |
MADISON,
WI
53718
|
|
Applicant Contact |
DAVID TRUEBLOOD |
Correspondent |
INO THERAPEUTICS |
2902 DAIRY DRIVE |
MADISON,
WI
53718
|
|
Correspondent Contact |
DAVID TRUEBLOOD |
Regulation Number | 868.5165
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/04/2012 |
Decision Date | 09/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|