Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K123614 |
Device Name |
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) |
Applicant |
TRUDELL MEDICAL INTL. |
725 THIRD ST. |
LONDON,
CA
N5V 5G4
|
|
Applicant Contact |
DARRYL FISCHER |
Correspondent |
TRUDELL MEDICAL INTL. |
725 THIRD ST. |
LONDON,
CA
N5V 5G4
|
|
Correspondent Contact |
DARRYL FISCHER |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 11/23/2012 |
Decision Date | 03/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|