Device Classification Name |
bronchoscope accessory
|
510(k) Number |
K152922 |
Device Name |
ViziShot FLEX |
Applicant |
SPIRATION, INC. |
6675 185th Ave NE |
REDMOND,
WA
98052
|
|
Applicant Contact |
Cyndy J Adams |
Correspondent |
SPIRATION, INC. |
6675 185th Ave NE |
REDMOND,
WA
98052
|
|
Correspondent Contact |
Cyndy J Adams |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 10/02/2015 |
Decision Date | 02/19/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|