Pulse Oximeter
by Shenzhen IMDK Medical Technology Co., Ltd EUDAMED510(k)
Active
510(k) K173123
Overview
The Pulse Oximeter is a non-invasive medical device used to measure oxygen saturation levels in arterial blood (SpO₂) and pulse rate. It operates by emitting light through a patient’s finger, earlobe, or other perfused tissue and detecting the absorption differences between oxygenated and deoxygenated hemoglobin, providing real-time physiological monitoring.
This device is supplied as a single-use or reusable (depending on model) and is intended for use in clinical settings such as hospitals, emergency rooms, and patient monitoring units. It adheres to FDA 510(k) clearance under the Cardiovascular advisory committee and EU MDR compliance, with no specific MRI safety restrictions noted. Storage conditions require protection from extreme temperatures and humidity, and proper calibration is essential for accurate readings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK173123 | Date13 Aug 2018 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- DQA
- FDA applicant
- Shenzhen Imdk Medical Technology Co., Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2700
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
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Questions
What clinical settings is this pulse oximeter designed for, and how does it differ between single-use and reusable models?
This pulse oximeter is designed for clinical settings like hospitals, emergency rooms, and patient monitoring units. The device is available in both single-use and reusable models, which likely cater to different hygiene and cost considerations. Single-use models are ideal for short-term or one-patient monitoring to minimize cross-contamination risk, while reusable models are suited for frequent use in high-traffic areas where sterilization between patients is feasible. The choice depends on facility protocols and patient care workflows.
How should I store this pulse oximeter to ensure accurate readings and device longevity?
Store the pulse oximeter in a dry environment protected from extreme temperatures and humidity, as these conditions can affect its performance. Proper storage is critical because moisture or temperature fluctuations may alter sensor sensitivity or calibration. Always follow manufacturer guidelines for packaging and shelf life, and avoid exposing the device to direct sunlight or harsh chemicals.
Can this pulse oximeter be used with any body part, or are there specific sites recommended for accurate readings?
This pulse oximeter is designed to measure oxygen saturation (SpO₂) and pulse rate through non-invasive sites like the finger, earlobe, or other well-perfused tissues. While it can technically be used on various body parts, accuracy may vary depending on tissue perfusion, movement, and ambient light. Fingers and earlobes are typically recommended for consistent readings, as they provide reliable light absorption for hemoglobin detection.
What regulatory pathways does this pulse oximeter follow, and how does that impact its use in the U.S. and EU?
This pulse oximeter follows both FDA 510(k) clearance under the Cardiovascular advisory committee in the U.S. and EU MDR compliance in Europe. The FDA clearance indicates it is deemed substantially equivalent to a predicate device, while MDR compliance ensures it meets EU safety, performance, and clinical data requirements. Clinicians should confirm local regulatory compliance before use, but no specific MRI restrictions are noted, meaning it can be used safely in non-MRI environments.