Masimo Lnop-Tf-I Resuable Transflectance Sensor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K032551 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 Masimo LNOP-TF-I Reusable Transflectance Sensor is a reusable transflectance sensor that utilizes two LEDs for light emission and measures light absorption for SpO2 and pulse rate calculation. It is compatible with Masimo SET pulse oximetry systems.
The sensor is supplied as a reusable device and is intended for use in settings where pulse oximetry is required. It has a stated accuracy of ± 2.0% SpO2 compared to arterial blood samples analyzed on a laboratory CO-Oximeter, and is cleared under FDA 510(k) number K032551.
Frequently asked questions
What is the Masimo LNOP-TF-I sensor used for?
The Masimo LNOP-TF-I sensor is used for measuring SpO2 and pulse rate in settings where pulse oximetry is required.
Is the Masimo LNOP-TF-I sensor reusable?
Yes, the Masimo LNOP-TF-I sensor is supplied as a reusable device, intended for multiple uses.
What is the stated accuracy of the Masimo LNOP-TF-I sensor?
The sensor has a stated accuracy of ± 2.0% SpO2 compared to arterial blood samples analyzed on a laboratory CO-Oximeter.
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 LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR (K032551) — FDA 510(k ..., Masimo - LNCS Reusables, Masimo - Wikipedia, K032551 FDA 510 (k) - MASIMO LNOP-TF-I RESUABLE TRANSFLECTANC...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032551 | Class II | Active |
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Manufacturer
- Manufacturer
- Masimo Corporation
- FDA Applicant
- Masimo Corp.
Sources (1)
- FDA 510(k) K032551 24 fields · synced Sep 22, 2026