510(k) Report

Devices descending from K892375

2 later devices reach Modified AM-Series Dialyzers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970650Asahi AM-R Series DialyzersAsahi Medical Co., Ltd.19971—
+2K991512Asahi AM-R-Series Dialyzers (Modified), Model AM-NR-XAsahi Medical Co., Ltd.199901