Shenzhen Med-Link Electronics Tech Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)January 8, 2026
K220448Disposable Non-invasive EEG SensorJanuary 19, 2023
K220447Med-link Disposable ECG Cable and LeadwiresJune 28, 2022
K212752Med-link Pulse OximeterMay 20, 2022
K210441Incontinence ProbeSeptember 17, 2021
K202743Med-Link Temp-pulse OximeterMarch 1, 2021
K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesAugust 25, 2020
K181154Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure MonitorAugust 2, 2019
K182667Med-link Temperature ProbesJune 18, 2019
K173869Med-link Reusable Blood Pressure CuffAugust 2, 2018
K160530Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure CuffNovember 28, 2016
K113727SHENZHEN MED-LINK PULSE OXIMETER PROBEMarch 21, 2013
K120010CABLE/ LEAD-WIRE (ECG, EKG, SPO2 AND INVASIVE BLOOD PRESSURE)January 19, 2012
K083010SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 June 10, 2009