Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K120939 |
Device Name |
AERONEB PRO |
Applicant |
AEROGEN LTD |
GALWAY BUSINESS PARK, DANGAN |
GALWAY,
IE
GALWAY
|
|
Applicant Contact |
MARTHA FOLAN |
Correspondent |
AEROGEN LTD |
GALWAY BUSINESS PARK, DANGAN |
GALWAY,
IE
GALWAY
|
|
Correspondent Contact |
MARTHA FOLAN |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 03/29/2012 |
Decision Date | 04/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|