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Zymed Model 1610

FDA 510(k)

Class II (US FDA 510(k))

510(k) K895208

by Agilent Technologies

Identifiers

510(k) Number
K895208 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 Zymed Model 1610 is a Detector and Alarm, Arrhythmia device, classified under FDA regulation 870.1025. It is designed to detect arrhythmias and provide audible or visual alarms to alert clinicians of abnormal cardiac rhythms, serving as a monitoring tool in cardiovascular settings.

This device is intended for single-use in clinical environments and has received FDA 510(k) clearance under a traditional review pathway. Supplied as a reusable or disposable component (as indicated by the product code DSI), it is regulated under Class II standards. No MRI safety information or sterility specifications are provided in the available data.

Frequently asked questions

What is the primary purpose of the Zymed Model 1610 in a clinical setting?

The Zymed Model 1610 is designed as a Detector and Alarm, Arrhythmia device, meaning it monitors cardiac rhythms to identify abnormal arrhythmias. When it detects irregularities, it triggers audible or visual alarms to alert clinicians, helping them respond promptly in cardiovascular care environments.

Is the Zymed Model 1610 intended for single-use or reusable applications?

The device is explicitly labeled for single-use in clinical environments, though the product code DSI indicates it may be supplied as either a reusable or disposable component depending on the specific configuration or accessories used.

What regulatory pathway was followed for FDA clearance of the Zymed Model 1610?

The Zymed Model 1610 received FDA 510(k) clearance through a traditional review pathway, with a decision dated December 12, 1989. It is classified under Class II standards and falls under FDA regulation 870.1025 for Detector and Alarm devices.

Are there any specific storage requirements mentioned for the Zymed Model 1610?

The provided data does not specify any particular storage conditions (e.g., temperature, humidity) for the Zymed Model 1610. Since it is intended for single-use, standard clinical storage practices for medical devices should be followed until use.

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: ZYMED MODEL 1610 510 (k) K895208 - FDA.report, ZYMED MODEL 1610 (K895208) — FDA 510 (k) | Innolitics, Zymed Model 1610 - Beudamed, Agilent Technologies FDA 510 (k) Products (1982-2001)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Agilent Technologies

Sources (1)

  • FDA 510(k) K895208 24 fields · synced Sep 19, 2026