510(k) Report

Devices descending from K213799

2 later devices reach N Series Patient Monitors through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250854Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12)…Shenzhen Comen Medical Instruments Co.,Ltd20250—
+1K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—