Mortara ELI 10 Electrocardiograph
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070539 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 Mortara ELI 10 is a 12-lead resting electrocardiograph device used for recording and transmitting electrocardiogram data. It is designed for clinical settings to capture cardiac electrical activity through 12-lead ECG recordings.
The device is supplied as a non-sterile, reusable medical equipment that requires setup and configuration by healthcare professionals. It is authorized under FDA 510K clearance with product code DPS and is restricted to sale by or on the order of a physician.
Frequently asked questions
What is the Mortara ELI 10 used for?
The Mortara ELI 10 is a 12-lead resting electrocardiograph device designed for clinical settings to capture and transmit electrocardiogram data, recording cardiac electrical activity through 12-lead ECG recordings.
How is the Mortara ELI 10 supplied and is it sterile?
The Mortara ELI 10 is supplied as non-sterile, reusable medical equipment that requires setup and configuration by healthcare professionals. It is not supplied in a sterile condition.
What is the regulatory status of the Mortara ELI 10?
The Mortara ELI 10 is authorized under FDA 510K clearance with product code DPS and is restricted to sale by or on the order of a physician. It received FDA clearance on March 15, 2007.
Is the Mortara ELI 10 a single-use device?
No, the Mortara ELI 10 is designed as a reusable medical device, not for single-use. It requires proper setup and configuration by healthcare professionals before each use.
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: MORTARA ELI 10 RX USER MANUAL Pdf Download | ManualsLib, ELI 10 User Manual Rev D1 PDF download, Mortara ELI 10 resting electrocardiograph User Manual, MORTARA ELI 10 RX USER MANUAL Pdf Download | ManualsLib, Manual Montara Eli10 | PDF - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070539 | Class II | Active |
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Manufacturer
- Manufacturer
- Mortara Instrument, Inc.
Sources (1)
- FDA 510(k) K070539 24 fields · synced Sep 27, 2026