Datex-Ohmeda S/5 Compact Anesthesia Monitor With L-CANE02 And L-CANE02A Software
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K022485 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Datex-Ohmeda S/5 Compact Anesthesia Monitor is a physiological patient monitor with arrhythmia detection or alarms. It is designed to monitor patients during anesthesia procedures, providing essential monitoring capabilities.
The device is manufactured by Datex-Ohmeda Inc. and is supplied as a reusable unit. It has received FDA 510(k) clearance with the K number K022485 and is classified as a Class II medical device under product code MHX. The device is intended for use in clinical settings where anesthesia monitoring is required.
Frequently asked questions
What is the Datex-Ohmeda S/5 Compact Anesthesia Monitor used for?
The S/5 Compact Anesthesia Monitor is a physiological patient monitor designed specifically for monitoring patients during anesthesia procedures. It includes arrhythmia detection capabilities and provides essential monitoring functions to ensure patient safety during anesthesia administration.
Is the Datex-Ohmeda S/5 Compact Anesthesia Monitor a single-use or reusable device?
The Datex-Ohmeda S/5 Compact Anesthesia Monitor is supplied as a reusable unit. It is designed for multiple uses in clinical settings where anesthesia monitoring is required, though proper cleaning and maintenance protocols should be followed between patients.
What regulatory approvals does the S/5 Compact Anesthesia Monitor have?
The device has received FDA 510(k) clearance with K number K022485 and is classified as a Class II medical device under product code MHX. It was determined to be substantially equivalent to other legally marketed devices through the traditional clearance process.
What are the key features of the S/5 Compact Anesthesia Monitor?
The S/5 Compact Anesthesia Monitor provides essential monitoring capabilities during anesthesia procedures, with a focus on arrhythmia detection or alarms. It is designed to be a compact yet comprehensive monitoring solution for clinical settings requiring anesthesia monitoring.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K022485 | Class II | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- FDA Applicant
- Datex-Ohmeda
Sources (1)
- FDA 510(k) K022485 24 fields · synced Oct 6, 2026