APK Technology Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
APK Technology Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Ultraviolet Phototherapy Device, Reusable SpO2 Sensors, Disposable SpO2 Sensors
5
Total
5
Cleared
0
Denied
APK Technology Co., Ltd. has 5 FDA 510(k) cleared medical devices. Based in No. 2 Road(S); Shanghai, CN.
Latest FDA clearance: Apr 2025. Active since 2009. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by APK Technology Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Mid-Link Consulting Co, Ltd. and Manton Business and Technology Services.
FDA 510(k) Regulatory Record - APK Technology Co., Ltd.
5 devices
Cleared
Apr 07, 2025
Ultraviolet Phototherapy Device
General & Plastic Surgery
52d
Cleared
Jun 08, 2018
Reusable SpO2 Sensors, Disposable SpO2 Sensors
Anesthesiology
254d
Cleared
Apr 24, 2017
ECG Disposable Lead Wire
Cardiovascular
60d
Cleared
Mar 02, 2011
BLOOD PRESSURE CUFF
Cardiovascular
154d
Cleared
Apr 03, 2009
APK SPO2 PULSE OXIMETER SENSOR
Anesthesiology
186d