510(k) Report

Devices descending from K001069

62 later devices reach Model 4000 Eeg Monitor with Psi (PSA4000) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020671PSA4000 Eeg Monitor with Frontal PsiPhysiometrix, Inc.200261—
+2K033999Sedline with Frontal PsiPhysiometrix, Inc.200460—
+3K051874Sedline Sedation Monitor with Frontal Psi and Sedtrace Eeg Electrose SetPhysiometrix, Inc.200559—
+4K140188Masimo Root Monitoring SystemMasimo Corporation201458—
+5K172890SedLine Sedation MonitorMasimo Corporation20185—
+5K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation201451—
+6K223574IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062)…Philips Medizin Systeme Boeblingen GmbH20232—
+6K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo Corporation20221—
+6K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation20160—
+6K151644Masimo Root Vital Signs Monitoring System and AccessoriesMasimo Corporation201624—
+6K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+7K260880SedLine Sedation MonitorMasimo Corporation20260—
+7K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH20250—
+7K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…Philips Medizin Systeme Böblingen GmbH20250—
+7K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+7K171121Masimo Root Monitoring System and AccessoriesMasimo Corporation201716—
+7K170168Masimo Rad-97 and AccessoriesMasimo Corporation201714—
+8K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+8K214115MightySat -OTCMasimo Corporation20241—
+8K230626Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services…Ge Medical Systems Information Technologies, Inc.202321
+8K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+8K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+8K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+8K200856SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20201—
+8K191882Masimo Centroid SystemMasimo Corporation20203—
+8K193242Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and…Masimo Corporation20207—
+8K1809033880 MRI Patient Monitoring SystemIradimed Corporation20190—
+8K181352Loop SystemSpry Health, Inc.201910—
+8K180046Masimo Rad-97 and AccessoriesMasimo Corporation2018131
+9K253417Masimo Root Monitoring SystemMasimo Corporation20260—
+9K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+9K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc.202401
+9K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+9K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+9K241758Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20240—
+9K240251ANNE ChestSibel Health, Inc.20240—
+9K232445CSF-4 (CSF-4)Cardiacsense20240—
+9K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application…Ge Medical Systems Information Technologies, Inc.202404
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K223498Radius VSM and AccessoriesMasimo Corporation202312
+9K212161Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and AccessoriesMasimo Corporation20230—
+9K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+9K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+9K222019Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse…Stryker Sustainability Solutions20221—
+9K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+9K220351Polso WatchChronisense Medical, Ltd.20220—
+9K210204Capsule Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20210—
+9K201770Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensorMasimo Corporation202012
+9K191059Masimo Rad-97 and AccessoriesMasimo Corporation20190—
+9K183697Masimo Rad-97 and AccessoriesMasimo Corporation20199—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+10K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K250757Radius VSM and AccessoriesMasimo Corporation20250—
+10K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+10K232915EpiMonitorEmpatica S.r.l.20241—
+10K231531Pediarity™Hinlab, Inc.20230—
+10K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+11K250515EpiMonitorEmpatica S.r.l.20250—