Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K080926 |
Device Name |
AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER |
Applicant |
TRUDELL MEDICAL INTL. |
725 THIRD ST. |
LONDON, ONTARIO,
CA
N5V 5G4
|
|
Applicant Contact |
DARRYL FISCHER |
Correspondent |
TRUDELL MEDICAL INTL. |
725 THIRD ST. |
LONDON, ONTARIO,
CA
N5V 5G4
|
|
Correspondent Contact |
DARRYL FISCHER |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 04/02/2008 |
Decision Date | 08/12/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|