S/5 Compact Critical Care Monitor With S-00C03 Or S-00C04 Software
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K002158 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 S/5 Compact Critical Care Monitor is a physiological patient monitor with arrhythmia detection or alarms. It is designed for critical care settings to monitor patients' vital signs and detect cardiac arrhythmias.
The monitor is supplied with S-00C03 or S-00C04 software and is manufactured by Datex-Ohmeda Inc. It is a Class II device with FDA 510K clearance (K002158) and is regulated under product code MHX. The device is intended for use in cardiovascular settings.
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 | K002158 | Class II | Active |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- FDA Applicant
- Datex-Ohmeda, Inc.
Sources (1)
- FDA 510(k) K002158 24 fields · synced Oct 6, 2026