510(k) K211153
K211153 is an FDA 510(k) premarket notification submitted by Mallinckrodt Manufacturing, LLC for the device "Inomax DSIR". The FDA issued a decision of Substantially Equivalent on April 20, 2023. The device falls under product code MRN (Apparatus, Nitric Oxide Delivery), a Class II device regulated under 21 CFR 868.5165. Mallinckrodt Manufacturing, LLC has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2023
- Date Received
- April 19, 2021
- Clearance Type
- Traditional
- 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