Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K021175 |
Device Name |
AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 |
Applicant |
AEROGEN, INC. |
1310 Orleans Dr. |
Sunnyvale,
CA
94089
|
|
Applicant Contact |
TRACI V. A EDWARDS |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 04/12/2002 |
Decision Date | 05/15/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|