510(k) Report

Devices descending from K221953

1 later device reach Masimo CARESCAPE SpO2 – Masimo with SpHb through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—