510(k) Report

Devices descending from K130322

3 later devices reach SPM-300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220535Cardio10Bionet Co., Ltd.20222—
+2K231160Cardio Q50, Cardio Q70Bionet Co., Ltd.20230—
+2K231150Cardio P1Bionet Co., Ltd.20230—