510(k) Report

Devices descending from K140582

6 later devices reach Fingertip Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182401B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared…Amzetta Technologies Private Limited20190—
+1K180685AS-3XX Series Fingertip Pulse OximeterXiamen Acurio Instruments Co., Ltd.20180—
+1K163135Finger Pulse OximeterShenzhen Fitfaith Technology Co.,Ltd20174—
+2K213984Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)Shenzhen Zhengkang Technology Co., Ltd.20220—
+2K203854Pulse OximeterShenzhen Hexin Zondan Medical Equipment Co., Ltd.20211—
+3K213430Fingertip Pulse OximeterShenzhen Witleaf Medical Electronics Co., Ltd.20220—