Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K201082 |
Device Name |
LTV2 Series Ventilators |
Applicant |
Vyaire Medical Inc |
26125 N. Riverwoods Blvd. |
Mettawa,
IL
60045
|
|
Applicant Contact |
Colleen Watson |
Correspondent |
Vyaire Medical Inc |
26125 N. Riverwoods Blvd. |
Mettawa,
IL
60045
|
|
Correspondent Contact |
Colleen Watson |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 04/23/2020 |
Decision Date | 11/10/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|