510(k) Report

Devices descending from K971273

22 later devices reach Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992340Masimo Set Radical Pulse Oximeter with Satshare, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp.1999211
+2K062144Escort M8 Vital Signs Patient Monitor, Model 3810Invivo Corporation200611—
+2K040178Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd.20045—
+2K030656Envan Heart Rate MonitorEnvan, LLC20030—
+2K022037Xltek Sleep SystemExcel Tech., Ltd.20020—
+2K02159996 Channel Eeg Headbox Model EMU96Excel Tech., Ltd.20020—
+3K202483MyHomeDocMyhomedoc, Ltd.20211—
+3K173589PrizmaG-Medical Innovations, Ltd.20180—
+3K170181PrizmaG-Medical Innovations, Ltd.20171—
+3K090556Spacelabs Elance Vital Signs Monitoring System and Central Monitor SoftwareSpacelabs Healthcare Medical Equipment (Suzhou) CO2009101
+3K080375RMX Physiological Data RecorderS.L.P., Ltd.20080—
+4K223785N9+Nonagon, Ltd.20230—
+4K130740Nightingale Monitoring SystemZoe Medical, Inc.20133—
+4K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc.201321
+4K093802Ultraview DM3 MonitorZoe Medical, Inc.201002
+4K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc.200912
+5K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc.20171—
+5K152043Diagnostic Station DS20Schiller AG20161—
+5K150329elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare20150—
+5K150620740 SelectCas Medical Systems, Inc.201501
+6K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+6K170182Cardiovit FT-1Schiller AG20170—