Agilent M2636A Telemon Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K001436 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 M2636A Telemon Monitor is a detector and alarm device for arrhythmia. It is designed to monitor cardiac rhythms and detect abnormal heart activity.
This device is manufactured by Agilent Technologies, Inc. and is supplied as a single-use or reusable product. It is not MRI safe and should be stored according to the manufacturer's instructions. The device has FDA 510(k) clearance with K001436 and is classified under product code DSI.
Frequently asked questions
What is the Agilent M2636A Telemon Monitor used for?
The Agilent M2636A Telemon Monitor is a detector and alarm device specifically designed to monitor cardiac rhythms and detect abnormal heart activity, making it useful for arrhythmia monitoring in clinical settings.
Is the Agilent M2636A Telemon Monitor single-use or reusable?
The Agilent M2636A Telemon Monitor is supplied as either a single-use or reusable product, depending on the specific configuration and intended use by the healthcare provider.
What is the regulatory status of the Agilent M2636A Telemon Monitor?
The Agilent M2636A Telemon Monitor has FDA 510(k) clearance with K001436 and is classified under product code DSI, indicating it has been determined to be substantially equivalent to predicate devices for detecting and alarming arrhythmia.
Is the Agilent M2636A Telemon Monitor MRI safe?
No, the Agilent M2636A Telemon Monitor is not MRI safe and should not be used in MRI environments or in close proximity to MRI equipment due to potential interference with the device's operation.
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: AGILENT M2636A TELEMON MONITOR (K001436) — FDA 510 (k) | Innolitics, K001436 FDA 510(k) - AGILENT M2636A TELEMON MONITOR, AGILENT M2636A TELEMON MONITOR (K001436) — FDA 510 (k) | Innolitics, PDF K001436 - Agilent M2636a Telemon Monitor, AGILENT M2636A TELEMON MONITOR 510(k) K001436 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001436 | Class II | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
Sources (1)
- FDA 510(k) K001436 24 fields · synced Oct 6, 2026