Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K001137 |
Device Name |
AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) |
Applicant |
TRUDELL MEDICAL INT'L |
725 THIRD ST. |
LONDON, ONTARIO,
CA
N5V 5G4
|
|
Applicant Contact |
TOM HOLBROOK |
Correspondent |
TRUDELL MEDICAL INT'L |
725 THIRD ST. |
LONDON, ONTARIO,
CA
N5V 5G4
|
|
Correspondent Contact |
TOM HOLBROOK |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 04/10/2000 |
Decision Date | 07/05/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|