510(k) Report

Devices descending from K955642

817 later devices reach Nellcor Symphony N-3000 Patient Monitor W/SP02 & Ecg/N-3200 Display/Printer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K212227Philips MR Patient Care PortalInvivo Corporation202101
+10K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+10K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+10K193626Masimo Rad-97 Pulse CO-Oximeter and AccessoriesMasimo Corporation20201—
+10K192595ExSpiron 2XiRespiratory Motion20190—
+10K183387M3290B Patient Information Center iXPhilips Medical Systems20190—
+10K152330Expression MR400 MRI Patient Monitoring SystemInvivo Corporation201521
+10K132359Mri Patient Monitoring SystemInvivo Corporation20130—
+11K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.20260—
+11K260211Dashboard (P007000)Hill-Rom, Inc.20260—
+11K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.20260—
+11K254066Etiometry PlatformEtiometry, Inc.20260—
+11K250151Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai20250—
+11K243866InVision Precision Cardiac AmyloidInVision Medical Technology Corporation20250—
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+11K212271smart-syncNorthh Medical GmbH20220—
+11K1829003880 MRI Patient Monitoring SystemIradimed Corporation20180—