510(k) K232814

Electronic Blood Pressure Monitor by Zhuhai Yueja Medical Device Technology Co., Ltd. — Product Code DXN

K232814 is an FDA 510(k) premarket notification submitted by Zhuhai Yueja Medical Device Technology Co., Ltd. for the device "Electronic Blood Pressure Monitor". The FDA issued a decision of Substantially Equivalent on December 5, 2023. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Zhuhai Yueja Medical Device Technology Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2023
Date Received
September 13, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type