510(k) Report

Devices descending from K091057

5 later devices reach Masimo Rainbow Set Pronto Pulse CO-Oximeter and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182887Masimo Rad-67 Pulse CO-Oximeter and AccessoriesMasimo Corporation20190—
+1K124041NBM-200MPOrsense, Ltd.20131—
+1K100403Masimo Rainbow Set Pronto -7 Pulse CO- Oximeter and Accessories, Model Pronto-7Masimo Corporation201011
+2K142209Pulse oximeter NBM-200Orsense, Ltd.20150—
+2K111403Masimo Rainbow Set Pronto-7 Pulse CO-Oximeter and AccessoriesMasimo Corporation20110—