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Blood Pressure Monitor (B73, BE23T)

by Shenzhen Jamr Technology Co., Ltd.

510(k) K251331

Active European Union and United States

CE MDR 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) K251331↗

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 · Traditional NumberK251331 Date27 Oct 2025ClearedStatusActive
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  • Withdrawn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/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DXN
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.

This device is a Blood Pressure Monitor, classified under FDA product code DXN and regulatory category 870.1130. It measures systolic and diastolic blood pressure and pulse rate, providing real-time cardiovascular readings for clinical or home use. Designed for accuracy and ease of use, it adheres to FDA standards for traditional 510(k) clearance under the Cardiovascular advisory committee.

The Blood Pressure Monitor (B73, BE23T) is supplied as a single-use or reusable device (sterility not specified) and is intended for use in non-MRI environments. It is available in models B73 and BE23T, with no explicit size specifications provided beyond the model designations. Authorised under FDA 510(k) and MDR, it requires proper storage per manufacturer instructions to maintain functionality and accuracy. No additional regulatory approvals beyond those stated are implied.

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