510(k) Report

Devices descending from K842616

165 later devices reach Spacelabs Alpha PC Patient Computer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K101127Patient Monitor, Model PM50Contec Medical System Co., Ltd.20100—
+6K100394Multi-Parameter Patient Monitor, Model# PMS8210AShanghai 3f Electronics Co, Ltd.20101—
+6K082787Vital Signs Monitor, Model: MD500BBeijing Choice Electronic Technololgy Co., Ltd.20090—
+6K080173STAR 55Larsen & Toubro Limited20085—
+6K072235PM-50 Pulse Oximeter and VS-800 Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.200772
+7K251881HippoMind (v1.0)Hippoclinic20250—
+7K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+7K211754Vital Signs MonitorBeijing Choice Electronic Technology Co., Ltd.20210—
+7K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+7K192343Patient MonitorShenzhen Creative Industry Co., Ltd.20190—
+7K190760Cadwell Bolt SoftwareCadwell Industries, Inc.20190—
+7K173036North-vision Multi-parameter Patient MonitorNorth-Vision Tech., Inc.20180—
+7K172792Handheld Pulse Oximeter, Model SP-20Shenzhen Creative Industry Co., Ltd.20183—
+7K173765Surveyor Patient MonitorMortara Instrument, Inc.201802
+7K172147STAR 65Skanray Technologies Pvt, Ltd.20180—
+7K172141Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20180—
+7K170047All-in-One Health Monitor, PC-303Shenzhen Creative Industry Co., Ltd.20176—
+7K170182Cardiovit FT-1Schiller AG20170—
+7K162199Cascade IOMAX Intraoperative MonitorCadwell Industries, Inc.201773
+7K152301Background Pattern Classification [BPc (TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20160—
+7K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+7K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+7K150352V Series Monitoring System (including V12 and V21 Monitors)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20151—
+7K132037Vital Signs MonitorMindray North America201432
+7K132038Accutorr 7 Vital Signs MonitorMindray North America20142—
+7K120485Nihon Kohden QP-160 AK Trend Program with the Addition of Dsa Asymmetry Trend and FFT PNihon Kohden America, Inc.20125—
+7K113183PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500Shanghai 3f Electronics Co, Ltd.20120—
+7K103686STAR 50 NLarsen & Toubro Limited20111—
+7K090172Star 55 Model 100Larsen & Toubro Limited20090—
+7K082685Galaxy 55Larsen & Toubro Limited20080—
+8K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbH20260—
+8K253436c-med0 alphaCosinuss GmbH20260—
+8K231625VitalDetectWellvii, Inc.20240—
+8K230415Cadwell GuardianCadwell Industries, Inc.20230—
+8K221113Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20220—
+8K213299Wireless EEG SystemPascall Systems, Inc.20222—
+8K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+8K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+8K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+8K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202111
+8K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+8K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+8K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+8K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+8K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+8K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+8K170712Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201711
+8K163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden Corporation20170—
+8K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+8K130238Nihon Kohden AE-918P Neuro UnitNihon Kohden Corp.20150—
+8K132033BM3/BM3 PlusNoblitt & Rueland20130—
+9K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.20260—
+9K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+9K240593VEEGix EEG SystemNeuroServo, Inc.20240—
+9K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+9K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202401
+9K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+9K222330The Heart SeatCasana Care, Inc.20230—
+9K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+9K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+9K212975MedWandMedwand Solutions, Inc.20221—
+9K213515WesperO2Wesper, Inc.20220—
+9K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+9K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.201901
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302