Device Classification Name |
Holding Chambers, Direct Patient Interface
|
510(k) Number |
K181649 |
Device Name |
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) |
Applicant |
Trudell Medical International |
725 Third Street |
London,
CA
N5V 5G4
|
|
Applicant Contact |
Marianne Tanton |
Correspondent |
Trudell Medical International |
725 Third Street |
London,
CA
N5V 5G4
|
|
Correspondent Contact |
Marianne Tanton |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 06/22/2018 |
Decision Date | 01/11/2019 |
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
|
|
|