Checkme O2 Pulse Oximeter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191088 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 Checkme O2 Pulse Oximeter is a non-invasive medical device classified as a pulse oximeter, designed to measure arterial oxygen saturation (SpO₂) and pulse rate in patients. It provides real-time monitoring of oxygen levels in the blood, aiding in the assessment of respiratory and circulatory function, particularly in clinical and home-care settings.
This device is supplied as a single-use or reusable unit, depending on the model variant, and is intended for use in both hospital and home environments. It adheres to FDA 510(k) clearance under the Traditional pathway, with a decision classification of Substantially Equivalent (SESE) within the Cardiovascular advisory committee category. Storage and handling follow standard medical device protocols to ensure accuracy and reliability.
Frequently asked questions
Is the Checkme O2 Pulse Oximeter designed for single-use only, or can it be reused after cleaning and sterilization?
The Checkme O2 Pulse Oximeter is available in both single-use and reusable variants, depending on the specific model. Reusable units must follow standard medical device cleaning and sterilization protocols to maintain accuracy and reliability, as outlined in the manufacturer’s instructions.
What types of environments is this pulse oximeter intended for, and how does its design support those settings?
The Checkme O2 Pulse Oximeter is designed for use in both clinical (hospital) and home-care settings. Its non-invasive design allows for real-time monitoring of arterial oxygen saturation (SpO₂) and pulse rate, making it versatile for assessing respiratory and circulatory function in diverse patient care scenarios.
How does the regulatory pathway for this device differ from other pulse oximeters, and what does the ‘Substantially Equivalent’ classification mean?
The Checkme O2 Pulse Oximeter follows the FDA’s Traditional 510(k) pathway with a classification of *Substantially Equivalent (SESE)* under the Cardiovascular advisory committee (product code DQA). This means the device’s safety and performance are deemed comparable to a legally marketed predicate device already on the market, ensuring compliance with FDA standards without requiring breakthrough innovation.
What storage and handling precautions should be taken to ensure the device remains accurate and reliable over time?
The device must be stored and handled according to standard medical device protocols, as specified by the manufacturer. This includes protecting it from physical damage, extreme temperatures, and contamination—especially for reusable models—to preserve its functionality and measurement accuracy in clinical or home settings.
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
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K191088 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Viatom Technology Co., Ltd.
Sources (2)
- FDA 510(k) K191088 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026