Bioma 3500
by E.B.S., Inc. 510(k)
Active
510(k) K872370
Overview
The Bioma 3500 is an Electrode, Surface, Electrocardiographic Tester, designed for evaluating and verifying the functionality of electrocardiographic electrodes. It falls under the classification of a cardiovascular diagnostic device, ensuring accurate signal transmission for cardiac monitoring applications.
This device is intended for use in clinical and research settings, where it is employed to test surface electrodes used in electrocardiographic (ECG) systems. Supplied as a reusable instrument, it adheres to regulatory standards as outlined in the FDA 510(k) clearance (K872370) under the Cardiovascular (CV) Advisory Committee. No specific sterility or MRI safety information is provided in the data, and it is classified as a Class II device under the FDA’s regulatory framework.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872370 | Date7 Dec 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KRC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2370
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from E.B.S., Inc.
Questions
What is the primary purpose of the Bioma 3500 in clinical settings and how does it differ from standard ECG monitoring equipment?
The Bioma 3500 is specifically designed as an Electrode, Surface, Electrocardiographic Tester to evaluate and verify the functionality of ECG electrodes. Unlike standard ECG monitoring equipment, which records cardiac signals, this device ensures electrodes transmit accurate signals reliably—critical for consistent ECG readings in both clinical and research environments.
Is the Bioma 3500 intended for single-use or reusable applications, and what does this mean for maintenance?
The Bioma 3500 is explicitly described as a reusable instrument, meaning it is built for repeated use across multiple patients or tests. This design implies it requires proper cleaning, calibration, and maintenance protocols to ensure consistent performance over time, reducing the need for disposable replacements.
How does the Bioma 3500’s regulatory pathway differ from other cardiovascular diagnostic devices, and what does the FDA 510(k) clearance indicate?
The Bioma 3500 follows the FDA 510(k) clearance pathway, classified as a Class II device under the Cardiovascular (CV) Advisory Committee. The clearance (K872370) indicates it was determined substantially equivalent to a legally marketed predicate device, meaning its safety and effectiveness were compared to an existing standard rather than undergoing full de novo review. This pathway is common for modifications or updates to established technologies.
Are there specific storage or handling requirements for the Bioma 3500, particularly regarding sterility or environmental conditions?
The provided data does not specify sterility requirements for the Bioma 3500, implying it is not intended for sterile procedures or direct patient contact beyond electrode testing. However, as a reusable device, it should be stored in a clean, dry environment to prevent contamination and ensure longevity. No MRI safety information is mentioned, so users should confirm compatibility if operating near magnetic fields.