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Accutorr 7/VS-900 Vital Signs Monitor

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

510(k) K170712

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK170712 Date2 Aug 2017ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0237-2020 FDA Class II initiated 1 Oct 2019

    NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function

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  • Withdrawn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
MWI
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Accutorr 7/VS-900 Vital Signs Monitor is a device intended for monitoring physiologic parameters in professional healthcare facilities. It measures pulse oximetry, pulse rate, non-invasive blood pressure, temperature, and carbon dioxide levels using inputs such as light absorption, oscillometric cuff pressure, and thermal resistance.

This monitor is suitable for applications ranging from spot checking to continuous monitoring. It has received FDA 510(k) clearance under the product code MWI. The device is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Other devices from Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.

Questions

AI-generated answers, 23 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 physiologic parameters can the Accutorr 7/VS-900 monitor?

    This device is designed to measure pulse oximetry, pulse rate, non-invasive blood pressure, temperature, and carbon dioxide levels. It utilizes various inputs, including oscillometric cuff pressure, light absorption, and thermal resistance, to track these vital signs in professional healthcare settings.

  • Is the Accutorr 7/VS-900 suitable for continuous patient monitoring?

    Yes, the monitor is versatile enough to support a range of clinical applications, extending from quick spot checks to continuous patient monitoring, depending on the needs of the healthcare facility.

  • What is the regulatory status of this vital signs monitor?

    The Accutorr 7/VS-900 Vital Signs Monitor has received FDA 510(k) clearance under the product code MWI. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.