510(k) Report

Devices descending from K234134

1 later device reach AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.20260—