510(k) Report

Devices descending from K123581

34 later devices reach Nellcor Oximax N-600X Pulse Oximeter, Nellcor Bedside Respiratory Patient… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142865Nellcor Bedside SpO2 Patient Monitoring SystemCovidien, LLC201531
+1K141518Nellcor Bedside Respiratory Patient Monitoring SystemCovidien201529—
+1K141542Nellcor Portable SPO2 Patient Monitoring System ( Npspms )Covidien, LLC20140—
+2K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+2K200594Capnostream 35 Portable Respiratory MonitorOridion Medical 1987, Ltd.20201—
+2K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+2K172482The Nellcor pulse oximetry monitor interface cableCovidien20171—
+2K152659V10Mediana Co., Ltd.20162—
+3K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC20260—
+3K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+3K214115MightySat -OTCMasimo Corporation20241—
+3K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+3K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+3K211632Pulse 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—
+3K201179GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableCovidien, LLC20200—
+3K181352Loop SystemSpry Health, Inc.201910—
+3K170497V10Mediana Co., Ltd.201711
+4K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+4K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+4K232445CSF-4 (CSF-4)Cardiacsense20240—
+4K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+4K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+4K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+4K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+4K220351Polso WatchChronisense Medical, Ltd.20220—
+5K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+5K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+5K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+5K252981EmbraceMiniEmpatica S.r.l.20251—
+5K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+5K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+5K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+5K232915EpiMonitorEmpatica S.r.l.20241—
+6K250515EpiMonitorEmpatica S.r.l.20250—