510(k) Report

Devices descending from K172154

2 later devices reach Isolette 8000 plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243437mOm Essential Incubator (ME1)Mom Incubators Limited20250—
+1K182977Isolette 8000 PlusDraeger Medical Systems, Inc.20180—