Device Classification Name |
analyzer, nitric oxide
|
510(k) Number |
K023014 |
Device Name |
VIANOX DELIVERY SYSTEM, MODEL I |
Applicant |
PULMONOX MEDICAL, INC. |
10835-120TH ST. |
SUITE 200 |
EDMONTON, AB,
CA
T5H 3P9
|
|
Applicant Contact |
PAULA TOMAT |
Correspondent |
PULMONOX MEDICAL, INC. |
10835-120TH ST. |
SUITE 200 |
EDMONTON, AB,
CA
T5H 3P9
|
|
Correspondent Contact |
PAULA TOMAT |
Regulation Number | 868.2380
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/10/2002 |
Decision Date | 08/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|