510(k) Report

Devices descending from K100046

16 later devices reach M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131762Handheld MonitorGuangdong Biolight Meditech Co., Ltd.20147—
+1K131876M Series Patient MonitorMid-Link Consulting Co, Ltd.20140—
+1K131763Truscope Series Patient MonitorGuangdong Biolight Meditech Co., Ltd.20130—
+1K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+1K112803Patient MonitorGuangdong Biolight Meditech Co., Ltd.20110—
+1K102040Patient MonitorGuangdong Biolight Meditech Co., Ltd.20101—
+2K232111NeoBeat, NeoBeat MiniLaerdal Medical AS20240—
+2K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+2K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+3K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+3K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+3K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+3K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+3K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+4K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+4K213515WesperO2Wesper, Inc.20220—