510(k) Report

Devices descending from K992340

21 later devices reach Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation200611—
+1K040178Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd.20045—
+1K030656Envan Heart Rate MonitorEnvan, LLC20030—
+1K022037Xltek Sleep SystemExcel Tech., Ltd.20020—
+1K02159996 Channel Eeg Headbox Model EMU96Excel Tech., Ltd.20020—
+2K202483MyHomeDocMyhomedoc, Ltd.20211—
+2K173589PrizmaG-Medical Innovations, Ltd.20180—
+2K170181PrizmaG-Medical Innovations, Ltd.20171—
+2K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+2K080375RMX Physiological Data RecorderS.L.P., Ltd.20080—
+3K223785N9+Nonagon, Ltd.20230—
+3K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+3K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+3K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+3K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+4K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+4K152043Diagnostic Station DS20Schiller AG20161—
+4K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+4K150620740 SelectCas Medical Systems, Inc.201501
+5K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+5K170182Cardiovit FT-1Schiller AG20170—