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12-LEAD ECG Adaptor for Use W/Lifepak 10 Defib/Mon

FDA 510(k)

Class II (US FDA 510(k))

510(k) K910144

by Physio-Control Corp.

Identifiers

510(k) Number
K910144 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
SESE Substantially Equivalent FDA 510(k)

The 12-Lead ECG Adaptor is a device designed for use with the LIFEPAK 10 Defibrillator/Monitor, enabling 12-lead electrocardiography functionality. This adaptor allows the defibrillator to capture and display 12-lead ECG data, which is essential for cardiac assessment and diagnosis during emergency situations.

The device is supplied as a Class II medical device under product code LDD with FDA 510(k) clearance K910144, granted on July 17, 1991. It is intended for single-patient use and should be stored according to manufacturer guidelines. The adaptor is compatible with the LIFEPAK 10 Defibrillator/Monitor system and is regulated under 870.5300 for low-energy DC defibrillators.

Frequently asked questions

What is the purpose of the 12-Lead ECG Adaptor for LIFEPAK 10?

The 12-Lead ECG Adaptor is designed to enable 12-lead electrocardiography functionality for the LIFEPAK 10 Defibrillator/Monitor, allowing it to capture and display 12-lead ECG data essential for cardiac assessment and diagnosis during emergency situations.

How is the 12-Lead ECG Adaptor supplied and what is its intended use?

The device is supplied as a Class II medical device under product code LDD with FDA 510(k) clearance K910144. It is intended for single-patient use and should be stored according to manufacturer guidelines.

Is the 12-Lead ECG Adaptor reusable or single-use?

The 12-Lead ECG Adaptor is intended for single-patient use, meaning it should be used for one patient and then disposed of or reprocessed according to the manufacturer's instructions.

What is the regulatory status of the 12-Lead ECG Adaptor?

The device has FDA 510(k) clearance K910144 granted on July 17, 1991, and is regulated under 870.5300 for low-energy DC defibrillators. It is classified as a Class II medical device under product code LDD.

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: 12-LEAD ECG ADAPTOR FOR USE W/LIFEPAK 10 DEFIB/MON 510 (k) K910144 ..., K910144 - 12-lead Ecg Adaptor for Use W/Lifepak 1..., Physio-Control LIFEPAK® 12 Biphasic Defibrillator (multiple options)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Physio-Control Corp.

Sources (1)

  • FDA 510(k) K910144 24 fields · synced Sep 22, 2026