Handheld Pulse Oximeter SP-20
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Handheld Pulse Oximeter FDA UDI
- Generic Name
- Pulse oximeter FDA UDI
- Device Name
- Handheld Pulse Oximeter EUDAMED
- Model / Reference
- SP-20 EUDAMEDFDA UDISP-20、PC-66A EUDAMEDPC-66A EUDAMEDPC-66B、PC-66B1、PC-66B2 EUDAMEDPC-66B2 EUDAMEDPC-66B1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941900606579 EUDAMED06941900603141 EUDAMED06941900606586 EUDAMED06941900603004 EUDAMED06941900604001 FDA UDI
- Basic UDI-DI
- 69419006HPOximeter0102HN EUDAMED69419006HPOximeter0101HL EUDAMED
- Direct Marketing DI
- 06941900606579 EUDAMED06941900603141 EUDAMED06941900606586 EUDAMED06941900603004 EUDAMED
- 510(k) Number
- FDA Product Code
- DQA FDA 510(k)FDA UDIFLL FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Pulse oximeter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)FDA UDI880.2910 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Handheld Pulse Oximeter SP-20 is a non-invasive medical device designed to measure and display functional oxygen saturation (SpO₂), pulse rate, and optionally temperature in adult and neonatal patients. It falls under the category of pulse oximeters, which monitor vital signs by analyzing light absorption through peripheral tissue.
This device is intended for use in clinical settings and home environments, providing real-time monitoring of SpO₂ and pulse rate. Supplied as a single-use or reusable unit (as per manufacturer specifications), it operates without MRI compatibility constraints. The SP-20 is authorized under FDA 510K clearance and MDR compliance, with regulatory submissions filed under product code DQA and advisory committee review.
Frequently asked questions
What vital signs does the Handheld Pulse Oximeter SP-20 measure, and is it suitable for both adults and children, including newborns?
The SP-20 measures functional oxygen saturation (SpO₂), pulse rate, and optionally temperature. It is designed for use in both adult and neonatal patients, making it versatile for clinical settings like hospitals and pediatric units, as well as home monitoring for patients of all ages.
How is the Handheld Pulse Oximeter SP-20 supplied, and can it be reused?
The SP-20 is supplied as either a single-use or reusable unit, depending on the manufacturer’s specifications. Since the device is intended for clinical and home use, the reusable option would require proper cleaning and maintenance to ensure accuracy and hygiene, while single-use units eliminate cross-contamination risks.
What regulatory approvals does the Handheld Pulse Oximeter SP-20 hold, and how was its submission reviewed?
The SP-20 holds FDA 510K clearance and MDR compliance. Its submission was reviewed under the product code DQA (Diagnostic, Clinical Chemistry) and the Cardiovascular (CV) advisory committee, with a decision of Substantially Equivalent (SESE) under traditional clearance. This means it was deemed comparable to legally marketed predicate devices.
Can the Handheld Pulse Oximeter SP-20 be used in an MRI environment, and what are its key operating constraints?
The SP-20 is not MRI-compatible, meaning it should not be used in magnetic resonance imaging environments due to potential interference or safety risks. Its primary constraints revolve around ensuring accurate readings in clinical or home settings where electromagnetic interference is minimal.
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: PDF SP-20 Manual - SHENZHEN CREATIVE INDUSTRY CO., LTD., PDF SP-20 Brochure - SHENZHEN CREATIVE INDUSTRY CO., LTD., Creative Industry SP-20 Handheld Pulse Oximeter User Manual, Creative SP-20 Pulse Oximeter Continuous Alarms
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K172792 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Creative Industry Co., Ltd.
Sources (6)
- FDA 510(k) K172792 24 fields · synced Sep 18, 2026
- FDA UDI 4ada2a11-788e-4d55-937b-11b856f2954b 33 fields · synced May 30, 2026
- EUDAMED 2a0b47e8-8fcf-4203-951d-4945a792eb5f 61 fields · synced Jun 20, 2026
- EUDAMED 1bd328fc-c62c-4908-bf0c-5ee396db44fc 61 fields · synced Jul 9, 2026
- EUDAMED f6898ebe-8963-4742-bab6-7c05f9197e7b 61 fields · synced Jul 11, 2026
- EUDAMED 03067546-a957-44ec-b0c4-f2ddb21310df 61 fields · synced Jul 28, 2026