Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K153748 |
Device Name |
AirLife Misty Finity Nebulizer |
Applicant |
CareFusion |
75 N Fairway Drive |
Vernon Hills,
IL
60047
|
|
Applicant Contact |
Erika Fernandez |
Correspondent |
Vyaire Medical |
26125 Riverwoods Blvd |
Mettawa,
IL
60045
|
|
Correspondent Contact |
Colleen O'Keeffe |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 12/29/2015 |
Decision Date | 05/17/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|