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Resmed Pty , Ltd.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K251661
Mariana Minerva; Mariana Nimbus
February 23, 2026
K242547
AirFit F20 Mask System; AirFit F20 NM Mask System
May 19, 2025
K203126
S10 Kirra
December 18, 2020