Orantech, Inc. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Orantech, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Patient Cables and Leadwires , Disposable ECG Leadwires, Temperature Probe, Disposable SpO2 Sensors, Reusable SpO2 Sensors
5
Total
5
Cleared
0
Denied
Orantech, Inc. has 5 FDA 510(k) cleared medical devices. Based in Shenzhen, CN.
Historical record: 5 cleared submissions from 2018 to 2019. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Orantech, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Chonconn Medical Device Consulting Co., Ltd. and Mid-Link Consulting Co, Ltd..
FDA 510(k) Regulatory Record - Orantech, Inc.
5 devices
Cleared
Jan 30, 2019
Patient Cables and Leadwires , Disposable ECG Leadwires
Cardiovascular
156d
Cleared
Oct 10, 2018
Temperature Probe
General Hospital
373d
Cleared
Sep 07, 2018
Disposable SpO2 Sensors, Reusable SpO2 Sensors
Anesthesiology
116d
Cleared
Aug 21, 2018
Reusable NIBP Cuff
Cardiovascular
323d
Cleared
May 31, 2018
ETCO2 Sensor
Anesthesiology
345d