510(k) Report

Devices descending from K213234

3 later devices reach CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…GE Healthcare Finland Oy20260—
+1K221953Masimo CARESCAPE SpO2 – Masimo with SpHbMasimo Corporation20221—
+2K232389Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVueMasimo Corporation20230—