ELI 380
ELI 380 is a multichannel resting electrocardiograph that acquires cardiac electrical signals through surface electrodes. Its colour display previews the ECG so the clinician can assess…
ELI 380 is a multichannel resting electrocardiograph that acquires cardiac electrical signals through surface electrodes. Its colour display previews the ECG so the clinician can assess recording quality before saving or printing.
The unit has a clamshell design, integrated thermal printer and glass-surface keyboard for patient information and controls. It operates from an internal battery or AC power and accepts direct or wireless patient connections.
Records and Interpretation
Acquired records can be reviewed, stored, printed or transmitted through the configured LAN, wireless LAN or USB interfaces. Adult and pediatric interpretive software assists physician review. A running buffer also permits selection of a preferred ten-second ECG segment.
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (2), Beijing (1). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Showing 12 of 18. All 18 manufacturers in China registered for Electrocardiograph
Record
| Listed by | Mortara Instrument, Inc., United States |
|---|---|
| FDA product code | DPS |
| Device type | Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2340 |
| 510(k) | K142105 |
| Record published | 2016-09-24 |
| Record revised | 2021-03-10 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity up to 95 % RH; Storage environment temperature up to 158 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ELI380-AAX43 | In distribution | |
| ELI380-DCS3X | In distribution | |
| ELI380-ABX4X | In distribution | |
| ELI380-FCS11 | In distribution | |
| ELI380-DCX3X | In distribution | |
| ELI380-ACS3X | In distribution | |
| ELI380-ACS21 | In distribution | |
| ELI380-AAS43 | In distribution | |
| ELI380-ACSXX | In distribution | |
| ELI380-ABS11 | In distribution | |
| ELI380-DAS43 | In distribution | |
| ELI380-ACX3X | In distribution | |
| ELI380-DCS11 | In distribution | |
| ELI380-DAX43 | In distribution | |
| ELI380-DAXXX | In distribution | |
| ELI380-ABS43 | In distribution | |
| ELI380-DAS21 | In distribution | |
| ELI380-DASXX | In distribution | |
| ELI380-AAX11 | In distribution | |
| ELI380-DCXXX | In distribution | |
| ELI380-ACX21 | In distribution | |
| ELI380-ACS43 | In distribution | |
| ELI380-ABX11 | In distribution | |
| ELI380-AASXX | In distribution | |
| ELI380-DCX11 | In distribution | |
| ELI380-DCX4X | In distribution | |
| ELI380-ABS21 | In distribution | |
| ELI380-DAS3X | In distribution | |
| ELI380-DBX21 | In distribution | |
| ELI380-DBS3X | In distribution | |
| ELI380-DCSXX | In distribution | |
| ELI380-DCS21 | In distribution | |
| ELI380-DBS21 | In distribution | |
| ELI380-DAX3X | In distribution | |
| ELI380-DBSXX | In distribution | |
| ELI380-DBX3X | In distribution | |
| ELI380-ACX11 | In distribution | |
| ELI380-ACS11 | In distribution | |
| ELI380-AAS3X | In distribution | |
| ELI380-ABX43 | In distribution | |
| ELI380-ACX4X | In distribution | |
| ELI380-DAX21 | In distribution | |
| ELI380-DAX11 | In distribution | |
| ELI380-DBS11 | In distribution | |
| ELI380-DBS4X | In distribution | |
| ELI380-DAX4X | In distribution | |
| ELI380-DAS11 | In distribution | |
| ELI380-ACS4X | In distribution | |
| ELI380-ACX43 | In distribution | |
| ELI380-DCS4X | In distribution | |
| ELI380-AAX3X | In distribution | |
| ELI380-DBX43 | In distribution | |
| ELI380-DCS43 | In distribution | |
| ELI380-AAX4X | In distribution | |
| ELI380-ABX3X | In distribution | |
| ELI380-DCX43 | In distribution | |
| ELI380-ABSXX | In distribution | |
| ELI380-DAS4X | In distribution | |
| ELI380-ABX21 | In distribution | |
| ELI380-DCX21 | In distribution | |
| ELI380-DBX4X | In distribution | |
| ELI380-DBXXX | In distribution | |
| ELI380-DBS43 | In distribution | |
| ELI380-DBX11 | In distribution | |
| ELI380-ABS4X | In distribution | |
| ELI380-AAS21 | In distribution | |
| ELI380-ABS3X | In distribution | |
| ELI380-AAS4X | In distribution | |
| ELI380-AAS11 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 1,734 |
| M Series Biphasic | Zoll Medical Corporation | 93 |
| Patient Cable Lead Set | Mortara Instrument, Inc. | 56 |
| ELI 250c | Mortara Instrument, Inc. | 50 |
| Lutech | Lutech Industries | 49 |
| ELI 150c | Mortara Instrument, Inc. | 47 |
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 41 |
| ELI 280 | Mortara Instrument, Inc. | 41 |
| Electrocardiograph | Edan Instruments, Inc. | 38 |
| Q-Stress | Mortara Instrument, Inc. | 25 |
| XScribe | Mortara Instrument, Inc. | 22 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 21 |
Showing 12 of 177. All products under Electrocardiograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152944 | 2016-01-06 |
| K142105 | 2014-09-05 |
| K122073 | 2012-08-02 |
| K120865 | 2012-07-19 |
| K102206 | 2011-02-18 |
| K101403 | 2010-07-02 |
| K101115 | 2010-06-18 |
| K100127 | 2010-04-16 |
| K093339 | 2010-02-19 |
| K092663 | 2009-12-14 |
| K082946 | 2008-12-29 |
| K070539 | 2007-03-15 |
| K062677 | 2006-11-15 |
| K031182 | 2003-07-25 |
| K022618 | 2002-09-06 |
| K930558 | 1993-04-27 |
| K922927 | 1992-11-10 |
| K864580 | 1987-02-20 |
| K861850 | 1986-08-28 |
| K861851 | 1986-08-28 |
| K832050 | 1983-12-13 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | 510(k) number | 2022-10-31 | Class II | Process control | One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022. | 1 unit | 2025-03-06 |
| Welch Allyn Inc Mortara | 510(k) number | 2021-03-31 | Class II | Process control | Devices do not meet IEC 60601-2-27 requirements as labeled. | 27 units | 2024-08-16 |
| Mortara Instrument, Inc. | 510(k) number | 2015-05-29 | Class II | Software design | 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 demo | 176 | 2015-08-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.