Device Classification Name |
Ventilator, Emergency, Powered (Resuscitator)
|
510(k) Number |
K202219 |
Device Name |
VORTRAN GO2VENT with PEEP Valve |
Applicant |
Vortran Medical Technology 1, Inc. |
21 Goldenland Court, Suite 100 |
Sacramento,
CA
95834
|
|
Applicant Contact |
Adam Palumbo |
Correspondent |
Vortran Medical Technology 1, Inc. |
21 Goldenland Court, Suite 100 |
Sacramento,
CA
95834
|
|
Correspondent Contact |
Adam Palumbo |
Regulation Number | 868.5925
|
Classification Product Code |
|
Date Received | 08/06/2020 |
Decision Date | 02/11/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|