Device Classification Name |
apparatus, nitric oxide delivery
|
510(k) Number |
K220898 |
Device Name |
NOxBOXi Nitric Oxide Delivery System |
Applicant |
Linde Gas & Equipment Inc. |
175 E Park Drive |
Tonawanda,
NY
14150
|
|
Applicant Contact |
Dave Loflin |
Correspondent |
Emergo Global Consulting, LLC |
2500 Bee Cave Road, Building 1, Suite 300 |
Austin,
TX
78746
|
|
Correspondent Contact |
Olga Lewis |
Regulation Number | 868.5165
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/28/2022 |
Decision Date | 04/27/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|