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Burdick Division E-500

FDA 510(k)

Class II (US FDA 510(k))

510(k) K861850

by Mortara Instrument, Inc.

Identifiers

510(k) Number
K861850 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Burdick Division E-500 is an electrocardiograph (ECG) device designed for recording and interpreting cardiac electrical activity. It falls under the product code DPS and is classified as a cardiovascular diagnostic device, enabling healthcare professionals to assess heart rhythms and diagnose potential cardiac conditions through graphical tracings of electrical signals.

This device is supplied by Mortara Instrument, Inc. and has undergone FDA 510(k) clearance under traditional review, with a decision date of August 28, 1986. It is intended for use in clinical settings, though specific sterility, single-use, or reusable details are not provided in the data. The device’s regulatory status is confirmed by its FDA 510(k) clearance (K861850) and advisory committee review by the Cardiovascular (CV) panel.

Frequently asked questions

What is the primary purpose of the Burdick Division E-500 ECG device in clinical practice?

The Burdick Division E-500 is designed to record and interpret cardiac electrical activity, allowing healthcare professionals to analyze heart rhythms and diagnose potential cardiac conditions. It generates graphical tracings of electrical signals, which are essential for assessing heart function and identifying abnormalities like arrhythmias.

How is the Burdick Division E-500 ECG device regulated by the FDA, and what does this mean for its use?

The Burdick Division E-500 received FDA clearance through a 510(k) traditional review process (K861850) and was deemed substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as determined by the Cardiovascular (CV) advisory committee in 1986, allowing its use in clinical settings for recording ECG tracings.

Is the Burdick Division E-500 intended for single-use or reusable applications, and what are its storage requirements?

The provided data does not specify whether the Burdick Division E-500 is single-use or reusable. Since it is a cardiovascular diagnostic device (product code DPS) and not explicitly described as disposable, it is likely intended for reusable clinical use in hospital or medical settings. Standard storage guidelines for ECG devices—such as protection from extreme temperatures, humidity, and electromagnetic interference—should be followed, though exact storage conditions are not detailed in the data.

What type of healthcare settings is the Burdick Division E-500 intended for, and who would typically operate it?

The Burdick Division E-500 is designed for clinical settings, including hospitals, cardiac care units, or physician offices where ECG monitoring is required. It is intended for use by healthcare professionals, such as cardiologists, nurses, or technicians, who are trained in interpreting cardiac electrical activity from the device’s graphical tracings.

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: BURDICK DIVISION (E-500) (K861850) — FDA 510 (k) | Innolitics, Burdick Division (e-500) 510 (k) FDA Premarket Notification K861850 ..., PDF K861850 BURDICK DIVISION (E-500) - 510kdatabase.net, PDF Siemens Burdick E500 E550 E600 Elite Physician Guide.pdf, Mortara Medical Equipment and Products | MedWrench

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Mortara Instrument, Inc.

Sources (1)

  • FDA 510(k) K861850 24 fields · synced Sep 18, 2026