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BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

510(k) K182075

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK182075 Date10 Dec 2018ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MHX
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 BeneVision N Series are physiological patient monitors designed for the detection of arrhythmias and the generation of alarms. These devices are used to track patient data and provide clinical monitoring capabilities.

This series includes the N1, N12, N15, N17, N19, and N22 models. The devices are authorized under FDA 510(k) clearance.

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See all devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. →

Questions

AI-generated answers, 27 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 primary function of the BeneVision N Series?

    These devices are physiological patient monitors engineered to track patient data, detect arrhythmias, and generate clinical alarms to support patient monitoring.

  • Which models are included in the BeneVision N Series?

    The series consists of six distinct models: the N1, N12, N15, N17, N19, and N22, all of which are covered under the same FDA 510(k) clearance.

  • What is the regulatory status of these monitors?

    The BeneVision N Series patient monitors are authorized under FDA 510(k) clearance, which indicates they have been found substantially equivalent to legally marketed predicate devices.