Pulse Oximeter MD300M/MD300K2
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Model / Reference
- MD300M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942820420122 EUDAMED
- Basic UDI-DI
- B-06942820420122 EUDAMED
- 510(k) Number
- K152563 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 Pulse Oximeter MD300M/MD300K2 is a non-invasive medical device used to measure arterial oxygen saturation (SpO₂) and pulse rate. It employs photoplethysmography to detect blood oxygen levels and heart rate by analyzing light absorption through peripheral tissue, such as a finger or earlobe.
This device is supplied as a single-use or reusable (depending on model variant) and is intended for use in clinical settings, including hospitals and outpatient care. It adheres to FDA 510(k) clearance under the product code DQA, with regulatory compliance under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The MD300M and MD300K2 variants are designed for accurate monitoring of patients’ oxygenation status and circulatory function.
Frequently asked questions
What are the key differences between the MD300M and MD300K2 models in terms of usage and design?
The MD300M and MD300K2 variants of the Pulse Oximeter differ primarily in their intended use for single-use versus reusable applications. The MD300M is designed for single-use, while the MD300K2 is intended for reusable clinical settings. Both models use photoplethysmography to measure arterial oxygen saturation (SpO₂) and pulse rate, but their durability and sterilization requirements will vary accordingly.
How is the Pulse Oximeter (MD300M/MD300K2) regulated, and what does that mean for its use in clinical settings?
The Pulse Oximeter (MD300M/MD300K2) holds FDA 510(k) clearance under product code DQA, indicating it is deemed substantially equivalent to a legally marketed device. It also complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in Europe, ensuring it meets stringent safety and performance standards for use in hospitals, outpatient care, and other clinical environments.
What body parts can the Pulse Oximeter (MD300M/MD300K2) be used on, and how does it measure oxygen levels?
The Pulse Oximeter (MD300M/MD300K2) is designed to measure arterial oxygen saturation (SpO₂) and pulse rate by analyzing light absorption through peripheral tissue. It can be used on a finger or earlobe, making it suitable for non-invasive monitoring of patients’ oxygenation status and circulatory function in clinical settings.
Is the Pulse Oximeter (MD300M/MD300K2) intended for home use, or is it strictly for professional clinical settings?
The Pulse Oximeter (MD300M/MD300K2) is explicitly intended for use in clinical settings, including hospitals and outpatient care. While it may have applications in other environments, its design and regulatory compliance (such as FDA 510(k) clearance under product code DQA) are tailored for professional medical monitoring rather than home use.
What does the advisory committee classification (Cardiovascular) mean for this device?
The Cardiovascular advisory committee classification for the Pulse Oximeter (MD300M/MD300K2) indicates that its submission was reviewed by the FDA’s Cardiovascular Panel during the 510(k) clearance process. This classification reflects that the device’s intended use—monitoring oxygen saturation and pulse rate—relates to cardiovascular health metrics, though it does not imply any specific clinical indication beyond its core function of measuring SpO₂ and heart rate.
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 | K152563 | Class II | Active |
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Manufacturer
- Manufacturer
- Beijing Choice Electronic Technology Co., Ltd.
Sources (2)
- FDA 510(k) K152563 24 fields · synced Sep 18, 2026
- EUDAMED 7650e086-763d-4e30-970d-44778f408713 61 fields · synced Jul 21, 2026