Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K141152 |
Device Name |
ADVANTAGE |
Applicant |
STEVENSON INDUSTRIES, INC. |
780 CHAMBERS LANE SUITE 200 |
SIMI VALLEY,
CA
93065
|
|
Applicant Contact |
SERRAH NAMINI |
Correspondent |
STEVENSON INDUSTRIES, INC. |
780 CHAMBERS LANE SUITE 200 |
SIMI VALLEY,
CA
93065
|
|
Correspondent Contact |
SERRAH NAMINI |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 05/05/2014 |
Decision Date | 10/17/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|