Identifiers
- 510(k) Number
- K093339 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 ELI PC Electrocardiograph is a 12-lead resting electrocardiograph designed to record and analyze cardiac electrical activity. Classified as a diagnostic electrocardiograph, it captures real-time heart rhythms and generates graphical representations of electrical impulses for clinical assessment. The device is intended for use in cardiac monitoring and diagnostic evaluation of patients’ heart conditions. Its functionality aligns with regulatory definitions for electrocardiographic devices, ensuring standardized cardiac diagnostics.
This device is supplied as a reusable medical instrument, intended for use in clinical settings such as hospitals, physician offices, and emergency care environments. It operates with disposable electrodes for patient contact, ensuring sterility and hygiene per single-use standards. The ELI PC Electrocardiograph is FDA-cleared under 510(k) classification (K093339) and adheres to cardiovascular advisory committee guidelines. Storage and maintenance follow manufacturer protocols to preserve performance and regulatory compliance.
Frequently asked questions
What is the ELI PC Electrocardiograph used for?
The ELI PC Electrocardiograph is designed to record and analyze cardiac electrical activity through 12-lead resting electrocardiography. It provides real-time heart rhythm data and graphical representations of electrical impulses, enabling clinicians to diagnose and evaluate patients’ heart conditions in settings like hospitals, physician offices, or emergency care.
Is the ELI PC Electrocardiograph reusable or single-use?
The ELI PC Electrocardiograph itself is a reusable medical instrument, built for repeated use in clinical environments. To maintain sterility and hygiene, it is paired with disposable electrodes for patient contact, ensuring compliance with single-use standards for patient safety.
What regulatory approval does the ELI PC Electrocardiograph hold?
The device is FDA-cleared under the 510(k) classification with the reference number K093339. It is classified as substantially equivalent to predicate devices and adheres to guidelines from the Cardiovascular Advisory Committee, ensuring its compliance with regulatory standards for electrocardiographic diagnostics.
How should the ELI PC Electrocardiograph be stored and maintained?
Storage and maintenance of the ELI PC Electrocardiograph follow manufacturer-provided protocols to preserve performance and regulatory compliance. These protocols typically include proper cleaning, calibration, and environmental conditions to ensure accurate and reliable operation over time.
Where can the ELI PC Electrocardiograph be used?
This device is intended for use in clinical settings such as hospitals, physician offices, and emergency care environments. Its design supports diagnostic cardiac monitoring and evaluation, making it suitable for environments where accurate electrocardiographic assessments are required.
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: ELI PC User Manual Rev A1 PDF download - BioClinical Services, MORTARA ELI 150 RX USER MANUAL Pdf Download | ManualsLib, ELI 150c Resting Electrocardiograph | Hillrom, Mortara Medical Equipment and Products | MedWrench
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093339 | Class II | Active |
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Manufacturer
- Manufacturer
- Mortara Instrument, Inc.
Sources (1)
- FDA 510(k) K093339 24 fields · synced Oct 1, 2026