Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K102240 |
Device Name |
NIVO NEBULIZER SYSTEM |
Applicant |
AEROGEN IRELAND, LTD. |
M&M QUALTECH, PARKMORE |
BUSINESS PARK |
GALWAY,
IE
|
|
Applicant Contact |
CAITRIONA CONNEELY |
Correspondent |
AEROGEN IRELAND, LTD. |
M&M QUALTECH, PARKMORE |
BUSINESS PARK |
GALWAY,
IE
|
|
Correspondent Contact |
CAITRIONA CONNEELY |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 08/09/2010 |
Decision Date | 11/10/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|