510(k) Report

Devices descending from K212876

2 later devices reach Carescape SpO2 - Masimo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+2K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—