AViTA Pulse Oximeter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Pulse oximeter EUDAMED
- Device Name
- Pulse oximeter EUDAMED
- Model / Reference
- SP64 EUDAMEDSP64P EUDAMEDSP66 EUDAMEDSP61 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710953426340 EUDAMED04710953425138 EUDAMED04710953424582 EUDAMED
- Basic UDI-DI
- 471095342TCF07SPXNB EUDAMED
- Direct Marketing DI
- 04710953426340 EUDAMED04710953425138 EUDAMED04710953424582 EUDAMED
- 510(k) Number
- K223399 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
- France EUDAMEDPoland 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 AViTA Pulse Oximeter SP61 is a non-invasive, battery-powered device classified as a pulse oximeter (Device Type: DQA). It measures oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate using spectrophotometry, emitting red and infrared light through a fingertip sensor.
This device is intended for spot-check monitoring in home and professional healthcare settings, designed for adult, adolescent, and pediatric patients with finger sizes ranging from 0.8 cm to 2.3 cm. It operates under no-motion conditions and is supplied as a reusable, multi-use instrument. Authorized under FDA 510(k) clearance (K223399) and MDR compliance, it requires adherence to standard regulatory guidelines for non-invasive monitoring devices.
Frequently asked questions
What types of patients can use the AViTA Pulse Oximeter SP61, and what finger sizes does it accommodate?
The AViTA Pulse Oximeter SP61 is designed for adults, adolescents, and pediatric patients and is suitable for finger sizes ranging from 0.8 cm to 2.3 cm. This broad range ensures compatibility with most patients, from infants to adults, making it versatile for home or professional healthcare settings.
Is the AViTA Pulse Oximeter SP61 intended for continuous monitoring, or is it meant for spot-check measurements?
The device is explicitly designed for spot-check monitoring, meaning it is not intended for continuous or prolonged use. It is optimized for occasional measurements of oxygen saturation (SpO₂) and pulse rate under no-motion conditions, making it ideal for quick assessments rather than ongoing tracking.
How is the AViTA Pulse Oximeter SP61 powered, and is it reusable or single-use?
The AViTA Pulse Oximeter SP61 is battery-powered and is classified as a reusable, multi-use instrument. This means it can be used repeatedly across multiple patients, provided proper cleaning and maintenance protocols are followed, as outlined in the manufacturer’s guidelines.
What regulatory pathways has the AViTA Pulse Oximeter SP61 followed, and which advisory committee was involved?
The device was cleared through the FDA 510(k) pathway under the product code DQA (Pulse Oximeters) and received a Traditional clearance with a decision code of SESE (Substantially Equivalent). The review was conducted under the Cardiovascular (CV) advisory committee as part of the AN (Advisory Non-Voting) review process, ensuring compliance with U.S. regulatory standards for non-invasive monitoring devices.
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: Avita Corporation FDA 510 (k) Products - Latest 2026, AViTA Pulse Oximeter (SP61) (K252448) — FDA 510(k) | Innolitics, AViTA Pulse Oximeter (K223399) — FDA 510 (k) | Innolitics
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 | K223399 | Class II | Active |
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Manufacturer
- Manufacturer
- Avita Corporation
Sources (4)
- FDA 510(k) K223399 24 fields · synced Sep 18, 2026
- EUDAMED d74e8a8a-f8fd-4bed-a496-31be01ce4eae 61 fields · synced Jul 15, 2026
- EUDAMED 875d8db6-af9a-4459-94a7-e9beb28bdc5b 61 fields · synced Jul 26, 2026
- EUDAMED aa8bee45-d748-489d-b380-3cc2d069efc0 61 fields · synced Jul 30, 2026