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iHealth View BP7S Wireless Blood Pressure Wrist Monitor

by Andon Health Co., Ltd.

510(k) K152379

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) K152379↗

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 · Special NumberK152379 Date23 Sep 2015ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR 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  • Withdrawn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/MDD, CE/MDR 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 iHealth View BP7S is a wireless blood pressure monitor designed for non-invasive measurement of systolic and diastolic blood pressure via the brachial artery, adhering to the nomenclature of a blood pressure monitor, wrist type (FDA Device Type). It provides real-time readings and wireless connectivity to compatible devices for data transmission, enabling continuous monitoring of cardiovascular health parameters.

This device is intended for single-use or reusable home use, supplied sterile or non-sterile as specified by the manufacturer. It operates in a non-MRI environment and is available in a single model (BP7S). Authorised under FDA 510K clearance (K152379) and compliant with MDD/MDR, it requires proper storage in a clean, dry environment to maintain accuracy and functionality. No additional regulatory approvals beyond those stated are implied.

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