← Back to catalogue

PM-8000 Patient Monitor, Model 8000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032733

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

Identifiers

510(k) Number
K032733 FDA 510(k)
FDA Product Code
DRT 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 PM-8000 Patient Monitor, Model 8000 is a cardiac patient monitoring device designed to continuously track and display vital signs such as heart rate and rhythm. Classified as a cardiac monitor (including cardiotachometer and rate alarm), it provides real-time physiological data to support clinical assessment and patient care in various healthcare settings. The device is intended for use in environments requiring reliable, portable monitoring capabilities.

This device is supplied as a reusable medical instrument and is intended for use in clinical settings where continuous cardiac monitoring is required. It features a high-resolution color display for clear visualization of patient data. The PM-8000 Patient Monitor, Model 8000, holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of March 3, 2004, and is categorized under device class 2. It is regulated under the Federal Food, Drug, and Cosmetic Act, specifically under regulation number 870.2300.

Frequently asked questions

Is the PM-8000 Patient Monitor reusable or single-use, and what does this mean for my clinical workflow?

The PM-8000 Patient Monitor, Model 8000, is designed as a reusable medical instrument, meaning it is intended for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. This makes it suitable for continuous cardiac monitoring in clinical settings like hospitals, ERs, or operating rooms where portability and long-term reliability are critical. Reusability also aligns with cost-effective workflows, as the device can be maintained and reused rather than discarded after single use.

What types of vital signs does the PM-8000 Patient Monitor specifically track, and why is this important for patient care?

The PM-8000 is primarily designed to continuously track and display heart rate and rhythm, functioning as a cardiac monitor (including a cardiotachometer and rate alarm). This is critical for real-time clinical assessment, especially in settings where cardiac stability is a priority, such as post-operative recovery, intensive care, or emergency departments. The device’s ability to provide immediate, high-resolution data helps clinicians quickly identify arrhythmias or other cardiac irregularities, enabling timely interventions.

How is the PM-8000 Patient Monitor regulated in the U.S., and what does its FDA clearance status imply for hospitals?

The PM-8000 holds an FDA 510(k) clearance under the Traditional pathway, classified as a Class II device under regulation number 870.2300. This clearance indicates the device meets FDA standards for safety and effectiveness as a cardiac monitor (including cardiotachometer and rate alarm). For hospitals, this implies compliance with U.S. medical device regulations, ensuring the device can be legally used in clinical settings while adhering to quality and performance requirements. The clearance also supports reimbursement and procurement processes.

Does the PM-8000 come with multiple models or configurations, and if so, how might this affect my purchasing decision?

The provided data specifies the PM-8000 Patient Monitor, Model 8000, as a single model, without additional variants or configurations listed. This suggests a standardized device designed for general-purpose cardiac monitoring in various clinical environments. If you require specialized features (e.g., pediatric-specific settings or additional sensors), you may need to verify compatibility with the base model or explore accessories. For most standard applications, this single model should suffice for reliable, portable monitoring.

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: Shenzhen Mindray Bio-Medical Electronics PM-8000 Service Manual, PDF Mindray PM-8000 Express Patient Monitor - User manual.pdf, Mindray PM8000 Patient Monitor - Auxo Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

  • FDA 510(k) K032733 24 fields · synced Oct 6, 2026