Shenzhen AOJ Medical Technology Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)June 23, 2025
K250161Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood PressureMay 2, 2025
K244000Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure MonitApril 30, 2025
K250116Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure MonitApril 24, 2025
K232989Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70July 1, 2024
K232128Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)October 14, 2023
K222994Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33BJuly 26, 2023
K221039Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M,December 20, 2022
K222125Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30GDecember 1, 2022
K221170Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107October 7, 2022
K213485Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25EMay 25, 2022
K213503Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35EFebruary 18, 2022
K202173Pulse OximeterDecember 7, 2020
K191180Electronic Blood Pressure MonitorAugust 23, 2019
K182190Fetal DopplerDecember 19, 2018
K182133Infrared ThermometerNovember 20, 2018