Identifiers
- 510(k) Number
- K083719 FDA 510(k)
- FDA Product Code
- NLF 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 Lncs Oximetry Sensors are oximetry sensors, classified as a type of oximeter. They are designed to measure oxygen saturation levels in patients.
The Lncs Oximetry Sensors are supplied in various sizes, including adult, pediatric, infant, and neonatal sizes. They are single-patient-use sensors and are compatible with Masimo Set pulse oximeters and Nellcor sensor compatible instruments. The sensors have a DB9 connector and are cabled. The device has received FDA 510K authorization.
Frequently asked questions
What sizes are the Lncs Oximetry Sensors available in?
The Lncs Oximetry Sensors are supplied in various sizes, including adult, pediatric, infant, and neonatal sizes, to accommodate different patient populations.
Are the Lncs Oximetry Sensors reusable?
No, the Lncs Oximetry Sensors are single-patient-use sensors, designed for use with one patient and then discarded.
What type of connector do the Lncs Oximetry Sensors have?
The Lncs Oximetry Sensors have a DB9 connector and are cabled, allowing for connection to compatible pulse oximeters.
What instruments are the Lncs Oximetry Sensors compatible with?
The Lncs Oximetry Sensors are compatible with Masimo Set pulse oximeters and Nellcor sensor compatible instruments.
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: Masimo - LNCS Sensors, Masimo - LNCS Single-patient-use Sensors, Masimo M-LNCS Sensors, 15-Pin | Pacific Biomedical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083719 | Class II | Active |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA 510(k) K083719 24 fields · synced Sep 24, 2026