Device Classification Name |
Apparatus, Nitric Oxide Delivery
|
510(k) Number |
K033779 |
Device Name |
VIANOX DELIVERY SYSTEM, MODEL II |
Applicant |
PULMONOX MEDICAL, INC. |
10835-120 ST. |
SUITE 200 |
EDMONTON, AB,
CA
T5H 3P9
|
|
Applicant Contact |
PAULA TOMAT |
Correspondent |
PULMONOX MEDICAL, INC. |
10835-120 ST. |
SUITE 200 |
EDMONTON, AB,
CA
T5H 3P9
|
|
Correspondent Contact |
PAULA TOMAT |
Regulation Number | 868.5165
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/04/2003 |
Decision Date | 01/26/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|