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Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor

by Andon Health Co., Ltd.

510(k) K210770

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210770↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK210770 Date29 Jul 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DXN
FDA applicant
Andon Health Co, Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor is a medical device designed to measure blood pressure on the arm. It operates wirelessly to provide blood pressure readings.

The device is supplied by Andon Health Co., Ltd. and has received FDA 510(k) clearance with the number K210770. It is classified under product code DXN and was reviewed by the CV advisory panel. The device is intended for single-patient use in clinical or home settings.

Other devices from Andon Health Co., Ltd.

See all devices from Andon Health Co., Ltd. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Arm Blood Pressure Monitor?

    The Arm Blood Pressure Monitor is designed to measure blood pressure on the arm and operates wirelessly to provide readings. It is intended for single-patient use in clinical or home settings.

  • How is the Arm Blood Pressure Monitor supplied?

    The device is supplied by Andon Health Co., Ltd. and is intended for single-patient use in clinical or home settings.

  • What is the regulatory status of this device?

    The device has received FDA 510(k) clearance with number K210770 and is classified under product code DXN. It was reviewed by the Cardiovascular advisory panel.

  • Can the Arm Blood Pressure Monitor be reused?

    No, the device is intended for single-patient use in clinical or home settings and should not be reused.