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ELI 200+ Audicor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031182

by Mortara Instrument, Inc.

Identifiers

510(k) Number
K031182 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 200+ Audicor is a Correlated Audioelectrocardiograph (COR) device designed to acquire, record, and store cardiac data. It integrates electrocardiographic (ECG) signals with simultaneous heart sound recordings, enabling correlated analysis of both electrical and acoustic cardiac activity for symptomatic patients.

This device is intended for use in clinical settings, where it operates as a reusable, non-sterile medical instrument. It is authorised under FDA 510(k) clearance (K031182) and falls under the DPS (Diagnostic, Patient Monitoring, Cardiovascular) product code. No specific sterility or MRI safety information is provided in the data.

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 200+ AUDICOR by MORTARA INSTRUMENT, INC. | FDA 510 (k) Summary, ELI 200+ AUDICOR (K031182) — FDA 510 (k) | Innolitics, ELI 200+ AUDICOR 510 (k) K031182 - FDA.report, PDF ELI 200 - Meena Medical

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) K031182 24 fields · synced Sep 19, 2026