Fingertip Pulse Oximeter MD300CN310
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161560 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 MD300CN310 is a handheld, non-invasive device classified as a pulse oximeter. It measures arterial hemoglobin oxygen saturation (SpO₂) and pulse rate (PR) in adult, adolescent, and pediatric patients. Designed for continuous monitoring, it provides real-time data to assess respiratory and circulatory status. The device operates via a fingertip sensor to deliver accurate, non-contact physiological readings.
This device is supplied as a reusable, non-sterile instrument intended for use in hospital settings, hospital-type facilities, and homecare environments. It requires two AAA-size batteries for operation and features an automatic power-off function to conserve energy. The MD300CN310 has received FDA 510(k) clearance under the Traditional pathway, with a clearance date of October 5, 2016. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What is the Fingertip Pulse Oximeter MD300CN310 used for?
The MD300CN310 is a non-invasive handheld device designed to measure arterial hemoglobin oxygen saturation (SpO₂) and pulse rate (PR) in patients across all age groups, including adults, adolescents, and children. It provides real-time monitoring to help assess respiratory and circulatory status, making it useful in hospital settings, hospital-type facilities, and homecare environments.
Is the MD300CN310 reusable or single-use?
The MD300CN310 is explicitly supplied as a reusable device. It is intended for repeated use in clinical environments, though it is not sterile and requires proper cleaning and maintenance between uses to ensure accuracy and hygiene.
What power source does the MD300CN310 use?
The device operates using two AAA-size batteries. It also features an automatic power-off function to conserve energy when not in use, ensuring prolonged monitoring sessions without frequent battery replacements.
Does the MD300CN310 require sterilization?
No, the MD300CN310 is supplied as a non-sterile device. Since it is reusable, it must be cleaned and disinfected between uses according to standard clinical protocols to maintain hygiene and prevent cross-contamination.
What regulatory pathway was followed for FDA clearance?
The MD300CN310 received FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. The clearance was granted on October 5, 2016, under K-number K161560.
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. Sources consulted: Fingertip Pulse Oximeter MD300CN310 (K161560) - Innolitics, Fingertrip Pulse Oximeter, Fingertip Pulse Oximeter MD300CN310 - healthcareequipment.org, Beijing Choice Electronic Technology Fingertip Pulse Oximeter Operator ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161560 | Class II | Active |
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Manufacturer
- Manufacturer
- Beijing Choice Electronic Technology Co., Ltd.
Sources (1)
- FDA 510(k) K161560 24 fields · synced Oct 1, 2026