Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K142541 |
Device Name |
POCKET NEB |
Applicant |
MicroVaper Devices |
2682 West Fairbanks Ave. |
Winter Park,
FL
32789
|
|
Applicant Contact |
Scott Faris |
Correspondent |
MicroVapor Devices |
2682 West Fairbanks Ave. |
Winter Park,
FL
32789
|
|
Correspondent Contact |
Terrence O'Brien |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 09/10/2014 |
Decision Date | 01/22/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|