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Disposable SpO2 Sensor

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K191279

by Shenzhen Caremed Medical Technology Co., Ltd.

Identifiers

510(k) Number
K191279 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 Disposable SpO₂ Sensor is a single-use pulse oximetry sensor designed to measure oxygen saturation (SpO₂) in blood non-invasively. It adheres to the nomenclature of a disposable pulse oximeter sensor and functions by transmitting light through tissue to detect hemoglobin oxygenation levels, providing real-time monitoring of arterial oxygenation.

This sensor is intended for single-use applications in clinical and home healthcare settings, ensuring sterility and hygiene compliance. Supplied in sterile packaging, it requires no sterilisation before use and is compatible with standard pulse oximeters. Authorised under FDA 510K and MDD, it adheres to regulatory standards for medical devices, with no MRI safety restrictions specified. Sizes or additional technical specifications are not detailed in the provided data.

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

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Caremed Medical Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K191279 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026