Device Classification Name |
apparatus, nitric oxide, backup delivery
|
510(k) Number |
K052663 |
Device Name |
INO THERAPEUTICS INOBLENDER, MODEL 10004 |
Applicant |
INO THERAPEUTICS |
7601-B MURPHY DRIVE |
MIDDLETON,
WI
53562
|
|
Applicant Contact |
FREDERICK MONTGOMERY |
Correspondent |
INO THERAPEUTICS |
7601-B MURPHY DRIVE |
MIDDLETON,
WI
53562
|
|
Correspondent Contact |
FREDERICK MONTGOMERY |
Regulation Number | 868.5165
|
Classification Product Code |
|
Date Received | 09/27/2005 |
Decision Date | 11/04/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|