510(k) Report

Devices descending from K093853

2 later devices reach Single-Patient Use Disposable Sensor Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103685Pulse Oximeter Sensor (Disposable and Reusable) Model RSA002DN, RSJ002DA, RSJ091DI…Beijing Rongrui-Century Scie. & Tech. Co., Ltd.20110—
+1K103584Envisen Nellcor, Bci, Nonin, Csi, HP/Philips, Datex-Ohmeda Compatible Disposable and…Shenzhen Envisen Industry Co. Limited20110—