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Digital Blood Pressure Monitor-Wrist Style

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K171833

by Shenzhen Combei Technology Co., Ltd

Identifiers

510(k) Number
K171833 FDA 510(k)
FDA Product Code
DXN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Digital Blood Pressure Monitor designed for wrist-based measurement, classified under the FDA’s product code DXN and reviewed by the Cardiovascular Advisory Committee. It is intended to measure systolic and diastolic blood pressure non-invasively, providing digital readouts for clinical or home monitoring purposes.

The monitor is supplied as a single-use or reusable device (as specified in its design), with FDA 510(k) clearance under the Traditional pathway, determined as Substantially Equivalent to a predicate device. It is intended for use in non-MRI environments and may be stored according to manufacturer guidelines (not specified in data). No sterility claims are stated in the provided records.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Shenzhen Combei Technology Co.,Ltd., Shenzhen Combei Technology Co.,Ltd., K171833 FDA 510(k) - Digital Blood Pressure Monitor-Wrist Style, Digital Blood Pressure Monitor-wrist Style 510 (k) FDA Premarket ..., Automatic blood pressure monitor - BPCB0A-PF - COMBEI TECHNOLOGY CO ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Combei Technology Co., Ltd
FDA Applicant
Shenzhen Combei Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K171833 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026