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M Seires Patient Monitor (M66 +4 more) - M8000

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K100046

by Guangdong Biolight Meditech Co., Ltd

Identifiers

510(k) Number
K100046 FDA 510(k)
FDA Product Code
MHX FDA 510(k)
Models / Variants
M66 FDA 510(k)EUDAMED
M69 FDA 510(k)EUDAMED
M8000 FDA 510(k)EUDAMED
M9000 FDA 510(k)EUDAMED
M7000 FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1025 FDA 510(k)
Regulation Number
870.1025 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The M Seires Patient Monitor is a physiological monitoring device designed for continuous assessment of patient vital signs, including arrhythmia detection and alarm capabilities. Classified as a Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms), it provides real-time monitoring of cardiac and respiratory parameters to support clinical decision-making in acute and critical care settings.

These monitors are intended for use in hospital environments, supplied as reusable medical devices, and comply with FDA 510K and MDR regulatory requirements. Models M66, M69, M8000, M9000, and M7000 are classified under device class 2 and feature multiple registration numbers for regulatory tracking. They are not MRI-safe and require proper storage and maintenance as per manufacturer guidelines.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangdong Biolight Meditech Co., Ltd
FDA Applicant
Guangdong Biolight Meditech Co., Ltd.

Sources (2)

  • FDA 510(k) K100046 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026