510(k) Report

Devices descending from K183512

2 later devices reach Moore Park Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K234134AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask SystemResmed Pty Ltd (Registration Number: 3004604967)20241—
+2K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—