Accutorr 7/VS-900/VS-900c Vital Signs Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182821 FDA 510(k)
- FDA Product Code
- MWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Accutorr 7/VS-900/VS-900c Vital Signs Monitor is a medical device classified as a Vital Signs Monitor (Product Code MWI). It is designed to measure and display physiological parameters such as blood pressure, heart rate, and other vital signs, enabling continuous or intermittent patient monitoring in clinical settings. The device supports real-time data acquisition and validation, facilitating accurate recording for electronic medical records (EMR). Its modular design accommodates various configurations, including wired and wireless connectivity options, to adapt to different healthcare workflows.
This device is intended for use in hospital and clinical environments, where it provides essential monitoring capabilities for patient care. Supplied as a reusable medical device, it requires proper sterilization and maintenance per manufacturer guidelines. The Accutorr 7/VS-900/VS-900c has received FDA 510(k) clearance under the Special 510(k) pathway, with a decision classification of Substantially Equivalent (SESE) within the Cardiovascular (CV) advisory committee. No third-party review was involved in its regulatory submission.
Frequently asked questions
What physiological parameters does the Accutorr 7/VS-900/VS-900c measure?
The Accutorr 7/VS-900/VS-900c Vital Signs Monitor is designed to measure and display blood pressure and heart rate, along with other vital signs. These parameters enable real-time monitoring for patient care in hospital and clinical environments, ensuring accurate data acquisition for electronic medical records (EMR).
Is the Accutorr 7/VS-900/VS-900c intended for single-use or reusable applications?
The Accutorr 7/VS-900/VS-900c is supplied as a reusable medical device. As such, it requires proper sterilization and maintenance following the manufacturer’s guidelines to ensure safety, reliability, and compliance with clinical standards.
What connectivity options does the Accutorr 7/VS-900/VS-900c support?
The device features a modular design that accommodates both wired and wireless connectivity options. This flexibility allows it to adapt to various healthcare workflows, improving usability in different clinical settings.
How does the Accutorr 7/VS-900/VS-900c integrate with electronic medical records (EMR)?
The Accutorr 7/VS-900/VS-900c is designed to facilitate real-time data acquisition and validation, enabling seamless integration with EMR systems. This ensures that monitored vital signs are accurately recorded and accessible for patient care.
What regulatory pathway was followed for the Accutorr 7/VS-900/VS-900c?
The device received FDA 510(k) clearance under the Special 510(k) pathway, with a decision classification of Substantially Equivalent (SESE) within the Cardiovascular (CV) advisory committee. This classification indicates that the device meets regulatory standards for safety and effectiveness.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: VS-900 Vital Signs Monitor - Mindray, MINDRAY VS-900C SERVICE MANUAL Pdf Download | ManualsLib, MINDRAY ACCUTOR 7 SERVICE MANUAL Pdf Download | ManualsLib, PDF The Accutorr 7 Vital Signs Monitor - Mindray
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182821 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Sources (1)
- FDA 510(k) K182821 24 fields · synced Oct 5, 2026