Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K063103 |
Device Name |
AG-EDGE, MODEL 91200 |
Applicant |
MEDEL S.P.A. |
112 CAVISTON WAY |
CARY,
NC
27519
|
|
Applicant Contact |
TERRENCE O'BRIEN |
Correspondent |
MEDEL S.P.A. |
112 CAVISTON WAY |
CARY,
NC
27519
|
|
Correspondent Contact |
TERRENCE O'BRIEN |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 10/10/2006 |
Decision Date | 01/08/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|