Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K072019 |
Device Name |
AKITA2 APIXNEB |
Applicant |
ACTIVAERO AMERICA, INC. |
3460 POINTE CREEK |
SUITE 102 |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
ACTIVAERO AMERICA, INC. |
3460 POINTE CREEK |
SUITE 102 |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 07/23/2007 |
Decision Date | 11/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|