510(k) K220898
K220898 is an FDA 510(k) premarket notification submitted by Linde Gas & Equipment, Inc. for the device "NOxBOXi Nitric Oxide Delivery System". The FDA issued a decision of Substantially Equivalent on April 27, 2022. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. Linde Gas & Equipment, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 27, 2022
- Date Received
- March 28, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Nitric Oxide Delivery
- Device Class
- Class II
- Regulation Number
- 868.5165
- Review Panel
- AN
- Submission Type