Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K143719 |
Device Name |
Aeroneb USB Contoller System |
Applicant |
Aerogen Limited |
Galway Business Park, Dangan |
Galway,
IE
|
|
Applicant Contact |
Martin Crehan |
Correspondent |
Aerogen Limited |
Galway Business Park, Dangan |
Galway,
IE
|
|
Correspondent Contact |
Martin Crehan |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 12/29/2014 |
Decision Date | 07/10/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|