Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. - FDA 510(k) Cleare...
Recent clearances: YUWELL® Electronic Blood Pressure Monitor (YE630CR), YUWELL® Electronic Blood Pressure Monitor (YE650AR), YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. Cardiovascular ✕
5 devices
Cleared
Mar 05, 2026
YUWELL® Electronic Blood Pressure Monitor (YE630CR)
Cardiovascular
184d
Cleared
Feb 23, 2026
YUWELL® Electronic Blood Pressure Monitor (YE650AR)
Cardiovascular
147d
Cleared
Oct 17, 2022
YUWELL Electronic Blood Pressure Monitor
Cardiovascular
158d
Cleared
Aug 20, 2020
Electronic Blood Pressure Monitor
Cardiovascular
134d
Cleared
Mar 27, 2018
Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood...
Cardiovascular
391d