510(k) K251889
K251889 is an FDA 510(k) premarket notification submitted by Resmed Corp for the device "myAir". The FDA issued a decision of Substantially Equivalent on April 8, 2026. The device falls under product code MNS (Ventilator, Continuous, Non-Life-Supporting), a Class II device regulated under 21 CFR 868.5895. Resmed Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2026
- Date Received
- June 20, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Non-Life-Supporting
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type