Device Classification Name |
Tube, Tracheostomy (W/Wo Connector)
|
510(k) Number |
K192511 |
Device Name |
Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm |
Applicant |
Venner Medical (Singapore) PTE Ltd |
35 Joo Koon Circle |
Singapore,
SG
629110
|
|
Applicant Contact |
Adrian P Waterton |
Correspondent |
Brauer Device Consultants, LLC |
7 Trail House Court |
Rockville,
MD
20850
|
|
Correspondent Contact |
Christine Brauer |
Regulation Number | 868.5800
|
Classification Product Code |
|
Date Received | 09/12/2019 |
Decision Date | 07/22/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|