ELI 280
ELI 280 is a multichannel resting electrocardiograph that acquires, analyzes, displays and prints ECG waveforms. It provides optional adult and pediatric interpretation for physician…
ELI 280 is a multichannel resting electrocardiograph that acquires, analyzes, displays and prints ECG waveforms. It provides optional adult and pediatric interpretation for physician review. The touchscreen shows waveforms, menu choices and status information, with an on-screen keyboard for patient data and controls.
The unit acquires signals through Mortara WAM wireless or AM12 acquisition modules and patient cables. It can store records for retrieval or transmission. A thermal printer produces ECG layouts and continuous rhythm printouts, while the display allows technicians to assess recording quality.
Clinical Interpretation
The device is intended for clinical use by physicians or trained personnel acting on their orders. Automated interpretation must be considered with physician review and other relevant patient information; it is not a sole diagnosis. ELI 280 is not intended as a vital-signs physiological monitor.
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) | K122073 |
| Record published | 2017-09-12 |
| Record revised | 2023-03-09 (version 7) |
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 |
| Distribution end date | 2023-03-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ELI280-CAC-AAFAX | In distribution | |
| ELI280-CAA-AAFBT | In distribution | |
| ELI280-CAA-AAFAX | In distribution | |
| ELI280-AAA-AAHBX | In distribution | |
| ELI280-AAA-AFCBX | In distribution | |
| ELI280-AAA-AAFAX | In distribution | |
| ELI280-AAA-AAFBX | In distribution | |
| ELI280-CAA-ACFBX | In distribution | |
| BUR280-C1X | In distribution | |
| ELI280-CAA-AAABX | In distribution | |
| ELI280-CAA-AAAAX | In distribution | |
| ELI280-AAA-AAFAD | In distribution | |
| ELI280-CAA-AAFBD | In distribution | |
| BUR280-W1X | In distribution | |
| ELI280-AAA-AAFAT | In distribution | |
| ELI280-CEA-ACFBD | In distribution | |
| ELI280-AAA-AAFBT | In distribution | |
| MLBUR280-81X | In distribution | |
| ELI280-AAA-AAHAD | In distribution | |
| ELI280-CDA-AAAAX | In distribution | |
| MLBUR280-C1D | In distribution | |
| MLBUR280-C1X | In distribution | |
| ELI280-CAA-AAFAD | In distribution | |
| BUR280-W1D | In distribution | |
| ELI280-CAA-AAFBX | In distribution | |
| MLBUR280-W1D | In distribution | |
| ELI280-CXX-ADFBD | In distribution | |
| ELI280-AAA-AAFBD | In distribution | |
| ELI280-AAA-AACBX | In distribution | |
| ELI280-AAA-AAAAX | In distribution | |
| BUR280-81X | In distribution | |
| MLBUR280-W1X | In distribution | |
| BUR280-C1D | In distribution | |
| BUR280-81D | In distribution | |
| MLBUR280-81D | In distribution | |
| ELI280-AAA-ABFBX | In distribution | |
| ELI280-CAA-AAFAT | In distribution | |
| ELI280-AXX-ADFAD | Withdrawn | |
| ELI280-CAC-CDFBT | Withdrawn | |
| ELI280-CAX-CDFBT | Withdrawn | |
| ELI280-CAC-AAFBX | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 1,734 |
| M Series Biphasic | Zoll Medical Corporation | 93 |
| ELI 380 | Mortara Instrument, Inc. | 69 |
| 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 |
| 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
2 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 |
|---|---|---|---|---|---|---|---|
| Welch Allyn Inc Mortara | 510(k) number | 2021-09-03 | Class II | Software design | The devices malfunction under specific operator workflows. | 14,630 units | |
| 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. | 99 units | 2024-08-16 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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.