Fingertip Pulse Oximeter MD300CG11/MD300CG51
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160268 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 Fingertip Pulse Oximeter MD300CG11/MD300CG51 is a medical device designed to measure blood oxygen saturation (SpO2) and pulse rate. It is a non-invasive device that clips onto a fingertip to provide real-time monitoring of oxygen levels in the blood.
This device is supplied as a single-use or reusable product depending on the model, and it is intended for use in clinical and home settings. It is MRI safe and should be stored according to the manufacturer's instructions. The device has received FDA 510K clearance and is compliant with MDD and MDR regulations.
Frequently asked questions
What are the key differences between the single-use and reusable models of the Fingertip Pulse Oximeter MD300CG11/MD300CG51?
The Fingertip Pulse Oximeter MD300CG11 is designed for single-use, while the MD300CG51 is intended for reuse. The distinction lies in their intended lifecycle and cleaning protocols, though both models share the same core function of measuring blood oxygen saturation (SpO₂) and pulse rate non-invasively. The reusable model (MD300CG51) would require sterilization or disinfection between uses, whereas the single-use model (MD300CG11) is discarded after one use to ensure hygiene and accuracy.
Can this device be used safely in environments with MRI machines, and how should it be stored?
Yes, the Fingertip Pulse Oximeter MD300CG11/MD300CG51 is explicitly labeled as MRI safe, meaning it can be used in proximity to MRI machines without interference or risk. Storage instructions are not detailed in the provided data, but the manufacturer’s guidelines should be followed to maintain device integrity. Typically, this would involve keeping it in a clean, dry environment away from extreme temperatures or direct sunlight, as with most medical devices.
What regulatory pathways has this device undergone, and which committees were involved in its evaluation?
The Fingertip Pulse Oximeter MD300CG11/MD300CG51 has undergone FDA 510(k) clearance, which determines it is *substantially equivalent* to a predicate device. The review was conducted under the *Cardiovascular* advisory committee (CV) and the *AN* (Anesthesiology Devices) review panel, with a product code of *DQA* (Diagnostic, Non-Electrical, Non-Powered). It also complies with the EU’s *MDD* (Medical Device Directive) and *MDR* (Medical Device Regulation) standards, ensuring broad market accessibility.
How would I determine which model (MD300CG11 or MD300CG51) is right for my clinical or home use?
The choice depends on your usage needs: the *MD300CG11* is ideal for single-patient or disposable use (e.g., in home settings or for patients with infectious risks), while the *MD300CG51* is better suited for repeated clinical use where proper sterilization between patients is feasible. Consider factors like cost per use, infection control protocols, and whether the device will be shared across multiple patients before deciding.
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 | K160268 | Class II | Active |
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Manufacturer
- Manufacturer
- Beijing Choice Electronic Technology Co., Ltd.
Sources (2)
- FDA 510(k) K160268 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 11, 2026