Nellcor Bedside Respiratory Patient Monitoring System
FDA 510(k)Class II (US FDA 510(k))
by Covidien
Identifiers
- 510(k) Number
- K141518 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 Nellcor Bedside Respiratory Patient Monitoring System is a pulse oximetry monitoring device designed to provide access to the status of a patient's oxygenation and respiration. It utilizes digital signal processing and cardiac-based technology to deliver accurate readings and assist in the early detection of respiratory complications.
This system is intended for bedside patient monitoring and supports consistent performance during challenging conditions such as patient movement. The device is authorized under FDA 510K clearance, identified by K-number K141518. It is manufactured by Covidien and supports on-site upgrades for new features and parameters.
Frequently asked questions
What is the primary function of the Nellcor Bedside Respiratory Patient Monitoring System?
This device is designed for bedside pulse oximetry monitoring. It uses digital signal processing and cardiac-based technology to track a patient's oxygenation and respiration status, helping clinicians detect respiratory complications early.
How does the system perform during patient movement?
The monitor is engineered to support consistent performance even during challenging clinical conditions, such as when a patient is moving, ensuring reliable data collection.
Can the device be updated after installation?
Yes, the system supports on-site upgrades. This allows healthcare facilities to add new features and monitoring parameters to the device as they become available without needing to replace the entire unit.
What is the regulatory status of this monitoring system?
The Nellcor Bedside Respiratory Patient Monitoring System is authorized under FDA 510K clearance, identified by K-number K141518. This indicates the device has been reviewed and found to be substantially equivalent to legally marketed predicate 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: Nellcor™ bedside respiratory patient monitoring system, Bedside patient monitoring - Medtronic, Nellcor Bedside Respiratory Monitor - Recertified | MME
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141518 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien
Sources (1)
- FDA 510(k) K141518 24 fields · synced Oct 6, 2026