510(k) Report

Devices descending from K160526

5 later devices reach Masimo O3 Regional Oximeter System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182429Masimo O3 Regional Oximeter SystemMasimo Corporation20193—
+1K162603Masimo O3 Regional Oximeter SystemMasimo Corporation20170—
+2K201432Masimo O3 Regional Oximeter SystemMasimo Corporation20202—
+3K214072Masimo O3 Regional Oximeter SystemMasimo Corporation20221—
+4K243324Masimo O3 Regional OximeterMasimo Corporation20250—