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510(k) K241613

Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) by Shenzhen Hbcare Technology Co.,Ltd — Product Code DXN

K241613 is an FDA 510(k) premarket notification submitted by Shenzhen Hbcare Technology Co.,Ltd for the device "Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)". The FDA issued a decision of Substantially Equivalent on October 16, 2024. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2024
Date Received
June 5, 2024
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

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FDA data resources