Wrist Pulse Oximeter

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K230587Ref MD300W628

by Beijing Choice Electronic Technology Co., Ltd.

Identity

Trade Name: Wrist Pulse Oximeter EUDAMED
Model / Reference: MD300W628 EUDAMED

Identifiers

Primary DI / UDI-DI: 06942820421037 EUDAMED
Basic UDI-DI: B-06942820421037 EUDAMED
510(k) Number: K230587 FDA 510(k)
FDA Product Code: DQA FDA 510(k)
EMDN Code: Z1203020408 PULSE OXIMETERS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Class 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

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

The Wrist Pulse Oximeter MD300W628 is a non-invasive patient monitoring device designed to measure oxygen saturation (SpO₂) and pulse rate via photoplethysmography. It falls under the category of pulse oximeters, which are classified as diagnostic and monitoring devices for assessing blood oxygen levels and heart rate in patients.

This device is intended for single-use or reusable applications in homecare, primary care, and clinical settings, depending on the model variant. Supplied sterile or non-sterile as specified, it adheres to FDA 510(k) clearance and MDD compliance, ensuring regulatory alignment. The device is non-MRI compatible and requires proper storage per manufacturer guidelines to maintain accuracy and functionality.

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 Manufacturer | Choicemmed, ChoiceMMed, Beijing Choice Electronic Technology Co., Ltd., Beijing Choice Electronic Technology Manuals & User Guides

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K230587	Class II	Active

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Manufacturer

Manufacturer: Beijing Choice Electronic Technology Co., Ltd.

Sources (2)

FDA 510(k) K230587 24 fields · synced Sep 18, 2026
EUDAMED 51cc695f-0a67-40e0-b1aa-04c1b3a354b8 61 fields · synced Aug 1, 2026