PC-60NW Fingertip Oximeter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120502 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 PC-60NW Fingertip Oximeter is a non-invasive medical device classified as a pulse oximeter, designed to measure oxygen saturation (SpO₂) and pulse rate (PR) in real time. It employs photoplethysmography to detect blood oxygen levels and pulse waveform via a fingertip sensor, providing continuous monitoring of vital signs. The device features a color display for clear visual output of SpO₂ and PR readings, along with a waveform display for additional diagnostic insight. Its compact design and fingertip application make it suitable for bedside, clinical, and portable patient monitoring settings.
The PC-60NW Fingertip Oximeter is supplied as a single-use or reusable device (sterility not specified) and is intended for use in regulated medical environments such as hospitals, clinics, or home healthcare. It operates without MRI compatibility constraints and is available in a single model configuration (PC-60NW). Storage requirements are not detailed, but standard medical device hygiene practices should be followed. Authorized for commercial distribution under FDA 510(k) clearance (K120502), it complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR)
Frequently asked questions
What types of environments is the PC-60NW Fingertip Oximeter designed for, and how does its compact design benefit users?
The PC-60NW Fingertip Oximeter is specifically designed for regulated medical settings like hospitals, clinics, and home healthcare environments. Its compact and portable design allows for easy use at the bedside, during patient transport, or in clinical examinations, making it versatile for continuous monitoring of vital signs without requiring a fixed workspace.
Can the PC-60NW Fingertip Oximeter be used in MRI environments, and what does this mean for its application?
The PC-60NW Fingertip Oximeter is explicitly stated to operate without MRI compatibility constraints. This means it can be safely used in non-MRI environments, but it should not be brought into an MRI room or used during MRI procedures, as electromagnetic interference could affect its performance or pose risks to the patient.
How does the PC-60NW Fingertip Oximeter differ from other pulse oximeters in terms of its display features?
Unlike basic pulse oximeters that only show numerical readings for oxygen saturation (SpO₂) and pulse rate (PR), the PC-60NW includes a color display for clear visibility of these values and also features a waveform display. This additional diagnostic insight helps clinicians assess the quality and regularity of the pulse waveform, improving the accuracy and reliability of patient monitoring.
Is the PC-60NW Fingertip Oximeter available in multiple models or sizes, and what does this mean for purchasing decisions?
The PC-60NW Fingertip Oximeter is available in a single model configuration (PC-60NW), meaning there are no variations in size or additional versions to choose from. This simplifies purchasing decisions, as buyers only need to order one model to meet their monitoring needs, ensuring consistency across clinical settings.
What regulatory pathways has the PC-60NW Fingertip Oximeter followed, and what does this imply for its compliance and distribution?
The PC-60NW Fingertip Oximeter has undergone FDA 510(k) clearance (K120502) under the Abbreviated review pathway, demonstrating it is substantially equivalent to a legally marketed device. It also complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), ensuring it meets stringent European regulatory standards. This regulatory route implies the device is authorized for commercial distribution in the U.S. and EU markets, adhering to safety and performance requirements.
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: Pc-60NW Fingertip Oximeter - OpenOximetry, CREATIVE PC-60NW USER MANUAL Pdf Download | ManualsLib, Creative Industry PC-60NW Fingertip Oximeter User Manual, PC60NW Fingertip Oximeter User Manual _3502-2290047_PC-60NW 英æ-‡è¯´æ ...
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 | K120502 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Creative Industry Co., Ltd.
Sources (2)
- FDA 510(k) K120502 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced Jun 18, 2026