510(k) Report

Devices descending from K961139

121 later devices reach Eagle Patient Monitor Model 3000/3100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231116Multi-parameter detectorZhongshan Jinli Electronic Weighing Equipment Co., Ltd.20240—
+8K233038Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sEdan Instruments, Inc.202401
+8K230415Cadwell GuardianCadwell Industries, Inc.20230—
+8K222330The Heart SeatCasana Care, Inc.20230—
+8K213431Handheld Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20230—
+8K212975MedWandMedwand Solutions, Inc.20221—
+8K212300Pulse OximeterShenzhen Mericonn Technology Co., Ltd.20220—
+8K212166ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20225—
+8K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+8K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+8K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+8K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+8K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.201901
+8K181466Cadwell Zenith SystemCadwell Industries, Inc.20180—
+8K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+8K153448Passport Series Patient Monitors (Including Passport 8, Passport 12)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.201602
+9K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+9K233292ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS XpressInomed Medizintechnik GmbH20231—
+9K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+9K213515WesperO2Wesper, Inc.20220—
+10K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302