Device Classification Name |
Spirometer, Therapeutic (Incentive)
|
510(k) Number |
K183108 |
Device Name |
Combined Aerobika OPEP and VersaPAP device |
Applicant |
Trudell Medical International |
725 Baransway Drive |
London,
CA
n5V 5G4
|
|
Applicant Contact |
Marianne Tanton |
Correspondent |
Trudell Medical International |
725 Third Street |
London,
CA
n5V 5G4
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 11/08/2018 |
Decision Date | 08/16/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|