Fingertip Pulse Oximeter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Pulse Oximeter EUDAMED
- Device Name
- Pulse Oximeter EUDAMED
- Model / Reference
- MD300C52 EUDAMEDMD300CI series, MD300CN1 series, MD300CN3 series, MD300C5 series, MD300C2 series, MD300C1 series, OX200 EUDAMEDMD300C29 EUDAMEDMD300CN310 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942820420037 EUDAMED06942820422447 EUDAMED06942820421556 EUDAMED
- Basic UDI-DI
- B-16942820420037 EUDAMED69428204SPO2VG EUDAMED
- Direct Marketing DI
- 06942820421556 EUDAMED
- 510(k) Number
- K130947 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
Classification
- Device Class
- Class IIa 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 EUDAMEDSpain 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
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The Fingertip Pulse Oximeter is a medical device that measures oxygen saturation levels and pulse rate through the fingertip. It provides non-invasive monitoring of blood oxygen levels and heart rate.
This device is supplied by Beijing Choice Electronic Technology Co., Ltd. and is authorized under FDA 510K, MDD, and MDR regulations. It is designed for single-use or reusable applications depending on the model, with various sizes available as specified by the manufacturer.
Frequently asked questions
What does the Fingertip Pulse Oximeter measure?
The Fingertip Pulse Oximeter measures oxygen saturation levels and pulse rate through the fingertip, providing non-invasive monitoring of blood oxygen levels and heart rate.
Is the Fingertip Pulse Oximeter single-use or reusable?
The device can be either single-use or reusable depending on the specific model selected by the user.
What regulatory authorizations does the Fingertip Pulse Oximeter have?
The device is authorized under FDA 510K, MDD, and MDR regulations, ensuring it meets certain regulatory standards.
What sizes are available for the Fingertip Pulse Oximeter?
Various sizes are available as specified by the manufacturer, Beijing Choice Electronic Technology Co., Ltd.
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
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K130947 | Class II | Active |
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Manufacturer
- Manufacturer
- Beijing Choice Electronic Technololgy Co., Ltd.
Sources (4)
- FDA 510(k) K130947 24 fields · synced Sep 18, 2026
- EUDAMED 432d3368-92f9-444f-96dd-990ddd5c2c0a 61 fields · synced Jul 20, 2026
- EUDAMED 18fbae8b-392c-4979-a55d-d09ea44cc1d5 61 fields · synced Jul 23, 2026
- EUDAMED 87285d07-fddf-4f3a-9363-0b15379159e7 61 fields · synced Jul 30, 2026