Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K162877 |
Device Name |
VOCSN Unified Respiratory System |
Applicant |
VENTEC LIFE SYSTEMS, INC |
19021 120TH AVE NE |
SUITE 101 |
BOTHELL,
WA
98011
|
|
Applicant Contact |
Joseph Cipollone |
Correspondent |
VENTEC LIFE SYSTEMS, INC |
19021 120TH AVE NE |
SUITE 101 |
BOTHELL,
WA
98011
|
|
Correspondent Contact |
Joseph Cipollone |
Regulation Number | 868.5895
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/14/2016 |
Decision Date | 04/07/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|