Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K140919 |
FOIA Releasable 510(k) |
K140919
|
Device Name |
RESPICONNECT ADAPTER |
Applicant |
TRUDELL MEDICAL INT'L |
725 THIRD ST. |
LONDON, ONTARIO,
CA
N5V 5G4
|
|
Applicant Contact |
DARRYL FISCHER |
Correspondent |
TRUDELL MEDICAL INT'L |
725 THIRD ST. |
LONDON, ONTARIO,
CA
N5V 5G4
|
|
Correspondent Contact |
DARRYL FISCHER |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 04/10/2014 |
Decision Date | 08/15/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|