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Oxyfit Pulse Oximeter

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K203812

by Shenzhen Viatom Technology Co., Ltd.

Identifiers

510(k) Number
K203812 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 Oxyfit Pulse Oximeter is a non-invasive device classified as a pulse oximeter, designed to measure arterial oxygen saturation (SpO₂) and pulse rate in patients. It provides real-time monitoring of blood oxygen levels and heart rate, aiding in the assessment of respiratory and circulatory function during clinical evaluations or home use.

This device is supplied as a single-use or reusable (depending on model) and is intended for use in clinical settings, including hospitals, outpatient facilities, and home monitoring environments. It adheres to FDA 510(k) clearance under the traditional pathway, with regulatory compliance also meeting the Medical Device Directive (MDD) and Medical Device Regulation (MDR) standards. The device is available in standard configurations, with no specific size variations noted in the specifications.

Frequently asked questions

What clinical scenarios is the Oxyfit Pulse Oximeter intended for monitoring, and how does it support patient assessment?

The Oxyfit Pulse Oximeter is designed for non-invasive monitoring of arterial oxygen saturation (SpO₂) and pulse rate, which are critical for assessing respiratory and circulatory function. It is suitable for use in clinical settings like hospitals, outpatient facilities, and home monitoring environments, where real-time tracking of blood oxygen levels and heart rate aids in evaluating patient stability during procedures, recovery, or chronic conditions.

Is the Oxyfit Pulse Oximeter available in multiple configurations, and if so, what variations should buyers expect?

The Oxyfit Pulse Oximeter is supplied in standard configurations, with no specific size variations mentioned in the specifications. However, it is available in both single-use and reusable models, allowing buyers to choose based on their facility’s infection control protocols and usage frequency.

How does the regulatory compliance of the Oxyfit Pulse Oximeter ensure its suitability for clinical use?

The device holds FDA 510(k) clearance through the traditional pathway, demonstrating substantial equivalence to a predicate device under the Cardiovascular advisory committee. It also complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR), ensuring adherence to stringent European regulatory standards for safety and performance.

What are the key differences between the single-use and reusable versions of the Oxyfit Pulse Oximeter, and how might they impact purchasing decisions?

The Oxyfit Pulse Oximeter is offered in both single-use and reusable models, which primarily differ in their intended lifespan and infection control implications. Single-use versions are ideal for minimizing cross-contamination risks in high-turnover settings, while reusable models reduce waste and costs for facilities with rigorous cleaning protocols. Buyers should consider their facility’s workflow, budget, and infection prevention needs when selecting between the two.

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

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Viatom Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K203812 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026