Electrocardiograph Ek-6 W/Optional Circ.
by Burdick Corp. 510(k)
Active
510(k) K760268
Overview
The Electrocardiograph EK-6 with Optional Circuit is a diagnostic device classified as an electrocardiograph (product code DPS). It records the electrical activity of the heart to generate a graphical representation of cardiac function, aiding in the assessment of cardiac health and the detection of arrhythmias or other abnormalities.
This device is intended for use in clinical settings, such as hospitals or cardiac care units, and was granted FDA 510(k) clearance under a Traditional review pathway by the Cardiovascular (CV) Advisory Committee. Supplied by Burdick Corp., it is regulated under the classification name 870.2340 and was determined to be Substantially Equivalent (SESE) to a legally marketed predicate device. No specific sterility, single-use, or MRI safety details are provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760268 | Date12 Nov 1976 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Burdick Corp.
Questions
What clinical setting is the Electrocardiograph EK-6 with Optional Circuit designed for, and how does it help in patient assessment?
The Electrocardiograph EK-6 with Optional Circuit is designed for use in clinical settings like hospitals or cardiac care units. It records the heart’s electrical activity to produce a graphical trace (EKG/EKG), which helps clinicians assess cardiac health, identify arrhythmias, and detect other abnormalities. This aids in diagnosing conditions such as irregular heartbeats, ischemia, or structural heart issues.
How is the Electrocardiograph EK-6 with Optional Circuit supplied, and what regulatory pathway was followed for its clearance?
The device is supplied by Burdick Corp. and was cleared through the FDA’s 510(k) Traditional review pathway, specifically under the Cardiovascular (CV) Advisory Committee. It was determined Substantially Equivalent (SESE) to a legally marketed predicate device, meaning it met FDA requirements for safety and effectiveness by demonstrating equivalence to an existing approved device.
Is the Electrocardiograph EK-6 with Optional Circuit intended for single-use or reusable applications, and what are its sterility or reuse guidelines?
The available data does not specify whether the Electrocardiograph EK-6 with Optional Circuit is single-use or reusable. Since no sterility claims or reuse instructions are mentioned, users should follow manufacturer guidelines (from Burdick Corp.) for cleaning, disinfection, or reprocessing if applicable. Always verify with the supplier for proper maintenance protocols.
What product code and classification does the FDA use for this device, and how does that affect its regulatory status?
The Electrocardiograph EK-6 with Optional Circuit is classified under FDA product code DPS (Diagnostic, Patient-Specific, Electrocardiographs) and falls under the classification name 870.2340. This classification determines its regulatory requirements, including labeling, performance standards, and post-market surveillance, but does not imply its intended clinical use—only how it is regulated.