Device Classification Name |
Cuff, Tracheal Tube, Inflatable
|
510(k) Number |
K173914 |
Device Name |
VORTRAN Cuff Inflator (VCI) |
Applicant |
VORTRAN Medical Technology 1, Inc. |
21 Goldenland Court |
#100 |
Sacramento,
CA
95834
|
|
Applicant Contact |
James Lee |
Correspondent |
VORTRAN Medical Technology 1, Inc. |
21 Goldenland Court |
#100 |
Sacramento,
CA
95834
|
|
Correspondent Contact |
James Lee |
Regulation Number | 868.5750
|
Classification Product Code |
|
Date Received | 12/22/2017 |
Decision Date | 05/25/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|