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Nihon Kohden TEC-7511A/TEC-7521A Cardiolife Portable Defibrillator and Accessories

FDA 510(k)

Class II (US FDA 510(k))

510(k) K971436

by Nihon Kohden America, Inc.

Identifiers

510(k) Number
K971436 FDA 510(k)
FDA Product Code
LDD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5300 FDA 510(k)
Regulation Number
870.5300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
ST FDA 510(k)

The device is a DC-defibrillator, low-energy, including paddles, intended for medical purposes. It delivers an electrical shock of a maximum of 360 joules of energy for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias.

It is supplied as a portable defibrillator with accessories and is classified under FDA 510(k) clearance K971436 with product code LDD and regulation number 870.5300. The device received traditional clearance on October 21, 1997, and is subject to tracking regulation.

Frequently asked questions

What is the NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE used for?

It is intended for medical purposes to deliver an electrical shock of up to 360 joules for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias, using low-energy DC-defibrillation with included paddles.

How is the NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE supplied and what does it include?

It is supplied as a portable defibrillator with accessories, including paddles, and is designed for use in clinical settings where cardiac defibrillation is required.

What regulatory pathway was used for the NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE?

The device received traditional FDA 510(k) clearance under K971436 on October 21, 1997, and is classified under product code LDD and regulation number 870.5300 for DC-defibrillators, low-energy, including paddles.

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: Nihon Kohden Tec-7511a/Tec-7521a Cardiolife Portable Defibrillator and ..., NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE… - FDA.report, www.accessdata.fda.gov

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) K971436 24 fields · synced Sep 25, 2026