510(k) Report

Devices descending from K043359

75 later devices reach 4100 Patient Oximeter Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191574OxSAT 100S.L.P., Ltd.20200—
+1K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp.200914—
+1K082113Nox T3, Noxturnal (PC Application)Nox Medical2008171
+1K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc.200840—
+2K242290DormoTech NLabDormotech Medical, Ltd.20250—
+2K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+2K143272ApneaLink AirResmed Germany, Inc.20157—
+2K131021Pulse OximeterNonin Medical, Inc.20133—
+2K124062QDC-Pro, and Nox-RipNox Medical20133—
+2K120462Audicor Cpam with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered…Inovise Medical, Inc.20123—
+2K121617SensicardiacDiacoustic Medical (Pty)201210—
+2K113865PultolSharp Corporation20120—
+2K110704SENSIDiacoustic Medical Devices (Pty), Ltd.201113—
+2K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.200910—
+3K191403Pulse OximeterNonin Medical, Inc.20191—
+3K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+3K172986Zmachine SynergyConsolidated Research of Richmond, Inc. Dba General Sleep CO20172—
+3K163665MATRx plusZephyr Sleep Technologies20173—
+3K151361Nox RIP Belts & CablesNox Medical Ehf20152—
+3K142888Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20158—
+3K140785Pulse OximeterNonin Medical, Inc.20140—
+3K131883Audicor Cpam with SDB (Accelerometer Based)Inovise Medical, Inc.20141—
+3K130660Audicor Cpam with SDB (Single Sensor)Inovise Medical, Inc.20130—
+3K131044Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd.20139—
+3K131287CardiosleeveRijuven Corp20131—
+3K111494Handheld Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20120—
+4K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH20260—
+4K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+4K242447Falcon HSTCompumedics Limited20250—
+4K214115MightySat -OTCMasimo Corporation20241—
+4K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+4K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+4K211632Pulse 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—
+4K202743Med-Link Temp-pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd.20210—
+4K201299HD StethHd Medical, Inc.20200—
+4K192624ApneaTrakCadwell Industries, Inc.20200—
+4K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+4K171304Maxxi Rip SensorNeurovirtual USA, Inc.20190—
+4K181988eMurmur IDCsd Labs GmbH20197—
+4K181352Loop SystemSpry Health, Inc.201910—
+4K181996MATRx PlusZephyr Sleep Technologies20182—
+4K181503Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20186—
+4K152091Fingertip Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology Co., Ltd.20160—
+4K151433AUDICOR CA300/CC100 Analyzer with SDBInovise Medical, Inc.20160—
+5K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20250—
+5K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+5K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+5K232975Pulse Oximeter (MD300C228)Beijing Choice Electronic Technology Co., Ltd.20240—
+5K232445CSF-4 (CSF-4)Cardiacsense20240—
+5K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+5K230172Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20231—
+5K230823AusculThing ACCAusculthing OY20230—
+5K220101Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20230—
+5K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+5K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+5K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+5K220351Polso WatchChronisense Medical, Ltd.20220—
+5K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+5K220766eMurmur Heart AICsd Labs GmbH20221—
+5K191925MATRx PlusZephyr Sleep Technologies20191—
+6K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+6K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+6K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+6K252981EmbraceMiniEmpatica S.r.l.20251—
+6K252284eMurmur Heart AICsd Labs20250—
+6K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+6K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+6K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+6K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd.20250—
+6K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+6K240901StethophoneSparrow Acoustics, Inc.20241—
+6K232915EpiMonitorEmpatica S.r.l.20241—
+6K200695MATRx plusZephyr Sleep Technologies20200—
+7K252595Stethophone ProSparrow Acoustics, Inc.20250—
+7K250515EpiMonitorEmpatica S.r.l.20250—