510(k) Report

Devices descending from K201456

6 later devices reach Scan Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243305Masimo W1Masimo Corporation20250—
+1K232512Masimo W1Masimo Corporation20232—
+1K230812Withings Scan Monitor 2.0Withings20230—
+1K221260CSF-3Cardiacsense20231—
+2K240229Masimo W1Masimo Corporation20241—
+2K232445CSF-4 (CSF-4)Cardiacsense20240—