510(k) Report

Devices descending from K925510

155 later devices reach Model 90478 & 90479 Telemetry Rec. Module&Housing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K211754Vital Signs MonitorBeijing Choice Electronic Technology Co., Ltd.20210—
+8K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+8K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+8K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+8K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+8K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+8K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+8K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+8K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+8K170182Cardiovit FT-1Schiller AG20170—
+8K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+8K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+8K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+8K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+8K132037Vital Signs MonitorMindray North America201432
+8K132038Accutorr 7 Vital Signs MonitorMindray North America20142—
+8K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+8K103686STAR 50 NLarsen & Toubro Limited20111—
+8K090172Star 55 Model 100Larsen & Toubro Limited20090—
+8K082685Galaxy 55Larsen & Toubro Limited20080—
+9K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+9K253436c-med0 alphaCosinuss GmbH20260—
+9K242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.202502
+9K242750Central StationNihon Kohden Digital Health Solutions, LLC20251—
+9K240312Infinity CentralStation WideDraeger Medical Systems, Inc.20240—
+9K232694Central Monitoring System (MFM-CMS)Edan Instruments, Inc.202411
+9K231625VitalDetectWellvii, Inc.20240—
+9K230415Cadwell GuardianCadwell Industries, Inc.20230—
+9K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+9K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+9K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+9K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+9K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202111
+9K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+9K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+9K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+9K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+9K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+9K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+9K170712Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201711
+9K132033BM3/BM3 PlusNoblitt & Rueland20130—
+10K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+10K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+10K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+10K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+10K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202401
+10K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+10K222330The Heart SeatCasana Care, Inc.20230—
+10K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+10K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+10K212975MedWandMedwand Solutions, Inc.20221—
+10K213515WesperO2Wesper, Inc.20220—
+10K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+10K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.201901
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302