Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Se…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K000822 FDA 510(k)
- FDA Product Code
- DSI 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 Agilent Component Monitoring System is a detector and alarm device designed for arrhythmia monitoring. It functions as a multi-measurement server and compact portable patient monitor to track cardiovascular data.
This device is authorized under FDA 510(k) clearance. It is classified as a class 2 medical device for use in cardiovascular clinical 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. Sources consulted: Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi ..., Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi ..., fda.innolitics.com, Agilent Component Monitoring System, Agilent Multi-measurement Server ..., Agilent Technologies… — 2 FDA 510 (k)s · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K000822 | Class II | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, GmbH
Sources (1)
- FDA 510(k) K000822 24 fields · synced Oct 6, 2026