510(k) Report

Devices descending from K000994

104 later devices reach Bipap Duet LX BI-Level System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K172875Astral 100/150Resmed, Ltd.20180Class I
+8K161492Juno VPAP ST-AResmed, Ltd.20171—
+8K161487VPAP Adapt SV, VPAP Tx, S9 VPAP TxResmed, Ltd.20160—
+9K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd.20260—