510(k) Report

Devices descending from K070193

15 later devices reach Envitec Oxipen Pulse Oximeter and Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133064Mysign S Pulse Oximeter, Mysign PC Software (Optional), Softtip Large R-3211-31, Finger…Envitec-Wismar GmbH20140—
+1K113165Mini-MedicAthena Gtx201213—
+2K190792BB-613WPBiobeat Technologies, Ltd.201912—
+3K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+3K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+3K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+3K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+3K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+4K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+4K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+4K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+4K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+4K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+5K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+5K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—