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Models WEP-8410A and WEP-8420A Telemetry Central

FDA 510(k)

Class II (US FDA 510(k))

510(k) K901034

by Nihon Kohden America, Inc.

Identifiers

510(k) Number
K901034 FDA 510(k)
FDA Product Code
DRT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2300 FDA 510(k)
Regulation Number
870.2300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Models WEP-8410A and WEP-8420A Telemetry Central is a cardiac monitor that includes cardiotachometer and rate alarm functions. This device is designed for monitoring cardiac activity in clinical settings.

The device is supplied by Nihon Kohden America, Inc. and has FDA 510(k) clearance with K number K901034. It is classified as Class II under product code DRT with special controls. The device is intended for cardiovascular use and was cleared as substantially equivalent on April 19, 1990.

Frequently asked questions

What is the Models WEP-8410A and WEP-8420A Telemetry Central used for?

This device is designed for monitoring cardiac activity in clinical settings and includes cardiotachometer and rate alarm functions to support continuous observation of heart rate and rhythm.

Who manufactures the Models WEP-8410A and WEP-8420A Telemetry Central?

The device is supplied by Nihon Kohden America, Inc., which is listed as the applicant and manufacturer in the FDA 510(k) clearance documentation.

What regulatory pathway was used for the Models WEP-8410A and WEP-8420A Telemetry Central?

The device received FDA 510(k) clearance under K number K901034, with a traditional clearance type and a substantially equivalent decision based on its cardiovascular monitoring capabilities.

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: Models Wep-8410a and Wep-8420a Telemetry Central, K901034 FDA 510(k) - MODELS WEP-8410A AND WEP-8420A TELEMETR..., Models Wep-8410a And Wep-8420a Telemetry Central 510 (k) FDA Premarket ..., Models Wep-8410a and Wep-8420a Telemetry Central - Beudamed, Nihon Kohden America Models Wep-8410A And Wep-8420A…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nihon Kohden America, Inc.

Sources (1)

  • FDA 510(k) K901034 24 fields · synced Sep 27, 2026