Device Classification Name |
Apparatus, Nitric Oxide Delivery
|
510(k) Number |
K171696 |
Device Name |
NOxBOXi Nitric Oxide Delivery System |
Applicant |
Praxair Distribution, Inc |
10 Riverview Drive |
Danbury,
CT
06810
|
|
Applicant Contact |
Michael E. Skrjanc |
Correspondent |
Praxair Distribution, Inc |
10 Riverview Drive |
Danbury,
CT
06810
|
|
Correspondent Contact |
Michael E. Skrjanc |
Regulation Number | 868.5165
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/07/2017 |
Decision Date | 10/02/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|