Home / 510(k) Clearances / K250185

510(k) K250185

Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) by Jiangxi Aicare Medical Technology Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2025
Date Received
January 22, 2025
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

Other clearances by Jiangxi Aicare Medical Technology Co., Ltd.

  • K221040 — Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) (August 31, 2022)

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