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510(k) K221040

Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) by Jiangxi Aicare Medical Technology Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2022
Date Received
April 7, 2022
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.

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