510(k) Report

Devices descending from K063011

5 later devices reach Mirage Liberty Full Face Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183512Moore Park MaskResmed, Ltd.20192Class I
+1K121747Facefit and Facefit Ported Non-Invasive Ventilation MasksIntersurgical Incorporated20130—
+1K112489Swift FX BellaResmed, Ltd.20110—
+2K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20241—
+3K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—