Handheld Pulse Oximeter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Handheld Pulse Oximeter EUDAMED
- Model / Reference
- MD300M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942820420129 EUDAMED
- Basic UDI-DI
- B-16942820420129 EUDAMED
- 510(k) Number
- K111494 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The Handheld Pulse Oximeter is a non-invasive monitoring device classified as a pulse oximeter (Device Type: DQA). It measures and displays oxygen saturation (SpO₂) in arterial blood by analyzing light absorption through peripheral tissue, providing real-time monitoring of oxygenation levels.
This device is intended for single-use or reusable applications in clinical and home settings, depending on manufacturer guidelines. Supplied in sterile or non-sterile packaging as specified, it adheres to FDA 510(k) clearance under Special Review (K111494) and MDD compliance. No MRI safety information is provided; users must follow manufacturer instructions for proper handling, storage, and usage.
Frequently asked questions
What clinical settings or environments is this handheld pulse oximeter designed for, and how does its single-use or reusable nature affect its use?
This handheld pulse oximeter is designed for both clinical and home settings, allowing flexibility depending on the user’s needs. It can be used as a single-use device or reused following manufacturer guidelines, which may include cleaning and sterilization protocols. The reusable option is ideal for healthcare facilities where multiple patients are monitored, while the single-use version is convenient for home use or short-term clinical assessments where sterility is a priority.
How does the device determine oxygen saturation (SpO₂) levels, and what type of tissue does it analyze?
The device measures oxygen saturation (SpO₂) in arterial blood by analyzing light absorption through peripheral tissue, typically the fingertip, earlobe, or forehead. It uses a non-invasive method where two LEDs emit different wavelengths of light, and the sensor detects how much light is absorbed or reflected by the blood. This data is processed to estimate the oxygen saturation level in real time.
Is this device sterile when supplied, and if not, what considerations should users take for storage and handling?
The device is supplied in either sterile or non-sterile packaging, depending on the specific model or configuration chosen by the manufacturer. If non-sterile, users must follow manufacturer instructions for proper cleaning, disinfection, and storage to prevent contamination. Sterile versions are ideal for clinical use where infection control is critical, while non-sterile versions may be suitable for home use or settings where reprocessing is feasible.
What regulatory pathways has this device followed, and how does that affect its availability or use in different markets?
This device has undergone FDA 510(k) clearance under Special Review (K111494) and complies with the Medical Device Directive (MDD). The FDA clearance indicates it is considered substantially equivalent to a predicate device, while MDD compliance ensures it meets European Union safety and performance standards. These pathways allow the device to be legally marketed in the U.S. and EU, though users should always verify local regulations and manufacturer guidelines for specific markets.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K111494 | Class II | Active |
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Manufacturer
- Manufacturer
- Beijing Choice Electronic Technololgy Co., Ltd.
Sources (2)
- FDA 510(k) K111494 24 fields · synced Sep 18, 2026
- EUDAMED e8234266-46eb-4f58-b30d-3034732d45cd 61 fields · synced Jul 10, 2026