Eli 380 ELI380-DAS3X
Eli 380 ELI380-DAS3X is a Class II device made by Mortara Instrument, Inc., cleared under FDA 510(k) K142105 on 5 Sep 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345026696), active as of 22 Oct 2026. 3 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00812345026696 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142105 | Date5 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 00812345026696
- FDA 510(k) database K142105
Across registries
- FDA 510(k) K142105 decided 5 Sep 2014 Active
- FDA GUDID UDI-DI 00812345026696 listed 24 Sep 2016 Listed
Recalls
-
- Terminated Z-1013-2023
One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
-
- Terminated Z-1483-2021
Devices do not meet IEC 60601-2-27 requirements as labeled.
-
- Terminated Z-1796-2015
Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electrocardiograph. When used in a particular workflow, acquired ECG waveforms for one patient may become associated with the patient demographics for a different patient when the record is transmitted to a records management system.
Timeline
- Cleared FDA 510(k) K142105
- Recall initiated FDA recalls Z-1796-2015
- Listed FDA GUDID 00812345026696
- Recall initiated FDA recalls Z-1483-2021
- Recall initiated FDA recalls Z-1013-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Eli 380
- Generic name
- Electrocardiograph, professional, multichannel
- Model / reference
- ELI380-DAS3X
- Primary DI / UDI-DI
- 00812345026696
- 510(k) Number
- FDA product code
- DPS
- GMDN term
- Electrocardiograph, professional, multichannel
- Device class
- Class II
- Regulation number
- 870.2340
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
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- Kardia 12L AC-027 by AliveCor
- Electrocardiograph SE-300B by Edan Instruments, Inc.
- ELI 280 ELI280-CAA-AAFBT by MORTARA INSTRUMENT, INC.
- ELI 380 ELI380-DCS21 by MORTARA INSTRUMENT, INC.