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Handheld Pulse Oximeter Model M800

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K101694

by Guangdong Biolight Meditech Co., Ltd

Identifiers

510(k) Number
K101694 FDA 510(k)
FDA Product Code
DQA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Handheld Pulse Oximeter Model M800 is a portable, non-invasive device designed to measure oxygen saturation (SpO₂) in arterial blood and pulse rate. It falls under the category of a pulse oximeter, a diagnostic tool used to monitor patients’ oxygenation levels in clinical and home settings.

This device is supplied as a single-use or reusable instrument, depending on manufacturer guidelines, and is intended for use in healthcare environments such as hospitals, clinics, or emergency settings. It operates without MRI compatibility restrictions and is authorised under FDA 510K clearance and MDR compliance, ensuring regulatory adherence for clinical applications. Storage and handling follow standard medical device protocols to maintain accuracy and sterility.

Frequently asked questions

What clinical settings is the Handheld Pulse Oximeter Model M800 approved for use in, and how does its portability factor into its utility?

The Model M800 is designed for use in healthcare environments like hospitals, clinics, and emergency settings, where portable, non-invasive monitoring of oxygen saturation (SpO₂) and pulse rate is required. Its handheld design makes it ideal for quick assessments in patient rooms, ambulances, or during patient transfers, ensuring flexibility in clinical workflows.

Is the Handheld Pulse Oximeter Model M800 single-use or reusable, and what does this mean for its maintenance and cost considerations?

The Model M800 can be supplied as either single-use or reusable, depending on manufacturer guidelines. If reusable, it must be cleaned and sterilized per standard medical device protocols to maintain accuracy and hygiene, which impacts maintenance costs and workflow. Single-use models eliminate sterilization needs but may incur higher per-unit costs.

What regulatory pathways does the Handheld Pulse Oximeter Model M800 follow, and how does this affect its adoption in global markets?

The device is authorized under FDA 510(k) clearance and MDR compliance, confirming its regulatory adherence in the U.S. and European markets. These pathways ensure it meets safety and performance standards, facilitating smoother adoption in healthcare settings where these certifications are required.

How should the Handheld Pulse Oximeter Model M800 be stored to ensure its accuracy and longevity, especially in clinical environments?

The device should be stored following standard medical device protocols to preserve its functionality and sterility. This typically includes keeping it in a clean, dry environment away from direct sunlight, extreme temperatures, or contaminants. Proper storage ensures consistent performance and extends its operational lifespan.

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: Gaming-Handhelds im Test: Das sind die besten Modelle

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) K101694 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026