510(k) Report

Devices descending from K971198

2 later devices reach Babytherm 8004 Babytherm 8010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993051Versalet 7700 Care Center, Model # 7700Hill-Rom Air-Shields20001—
+2K053399Versalet 7700 Care CenterDraeger Medical Infant Care, Inc.20060—