510(k) Report

Devices descending from K853124

16 later devices reach Novametrix Pulse Oximeter, Model 500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200567ASI Plethysmogrpah AnalyzerArterial Stiffness, Inc.20210—
+1K120052CvinsightIntelomed, Inc.20120—
+1K023238McpulseMeridian Co., Ltd.200314—
+2K243566CardioTag™Cardiosense, Inc.20250—
+2K111013ACEMSandhill Scientific, Inc.20110—
+2K110374Max Pulse SystemMedicore Co., Ltd.20110—
+2K083229E.S Teck ( Electro Sensor Teck)Ld Technology, LLC20095—
+2K073323SA-3000PMedicore Co., Ltd.20073—
+3K102442E.S.O. (Electro Sensor Oxi)Ld Technology, LLC20104—
+3K083735Ansha Autonomic Nervous System Health Assessment PlusMedtechs, LLC20092—
+4K191266VitalScan ANSMedeia, Inc.20200—
+4K160956LD-Oxi systemLd Technology, LLC20162—
+4K130056Patient MonitorLd Technology, LLC20130—
+4K101983Critical Care AssessmentCritical Patient Care, Inc.20101—
+5K200141Oxi-W SystemLd Technology, LLC20201—
+6K253306BioTracker 2.0Biotracker, LLC20260—