510(k) Report

Devices descending from K972282

124 later devices reach Spacelabs Medical Pcis Patient Monitors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K210086Vitals360 Multi-Vitals Mobile MonitorVocare, Inc.20214—
+7K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+7K202892Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202111
+7K201468Pulse OximeterShenzhen Creative Industry Co., Ltd.20212—
+7K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+7K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+7K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+7K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+7K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+7K170712Accutorr 7/VS-900 Vital Signs MonitorShenzhen Mindray Bio-Meidcal Electronics Co., Ltd.201711
+7K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+7K132033BM3/BM3 PlusNoblitt & Rueland20130—
+8K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+8K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+8K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202401
+8K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+8K222330The Heart SeatCasana Care, Inc.20230—
+8K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+8K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+8K212975MedWandMedwand Solutions, Inc.20221—
+8K213515WesperO2Wesper, Inc.20220—
+8K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+8K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.201901
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302