The following data is part of a premarket notification filed by Praxair, Inc. with the FDA for The Noxboxi Nitric Oxide Delivery System.
Device ID | K201339 |
510k Number | K201339 |
Device Name: | The NOxBOXi Nitric Oxide Delivery System |
Classification | Apparatus, Nitric Oxide Delivery |
Applicant | Praxair, Inc. 10 Riverview Drive Danbury, CT 06810 |
Contact | Dave Loflin |
Correspondent | Sarah Marie Fitzgerald Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
Product Code | MRN |
Subsequent Product Code | CCL |
Subsequent Product Code | MRO |
Subsequent Product Code | MRP |
Subsequent Product Code | MRQ |
CFR Regulation Number | 868.5165 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-05-20 |
Decision Date | 2020-06-19 |