Electrocardiograph
The FDA filing lists SE-601A and SE-601C among three models in the SE-601 Series Electrocardiograph. It describes use as acquiring signals from adult and pediatric patients through body…
The FDA filing lists SE-601A and SE-601C among three models in the SE-601 Series Electrocardiograph.
It describes use as acquiring signals from adult and pediatric patients through body surface electrodes, in hospitals or healthcare facilities with doctors and trained healthcare professionals.
Use and Interpretation
The filing says a recorded cardiogram can help users analyze and diagnose heart disease. Interpreted measurements and statements are intended only for adults and offered to clinicians on an advisory basis.
The device description also lists automatic analysis and diagnostic software for adults and pediatric patients.
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 | Edan Instruments, Inc., China |
|---|---|
| FDA product code | DPS |
| Device type | Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2340 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K131503 |
| Record published | 2017-02-12 |
| Record revised | 2026-05-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SE-601A | In distribution | |
| ECG-1201 | In distribution | |
| SE-1201Pro | In distribution | |
| SE-1200 | In distribution | |
| SE-601B | In distribution | |
| ECG-12C | In distribution | |
| SE-600 | In distribution | |
| SE-12 | In distribution | |
| SE-601C | In distribution | |
| ECG-1200 Plus | In distribution | |
| SE-1200 Express | In distribution | |
| ECG-12 | In distribution | |
| ECG-3 | In distribution | |
| ECG-12 Plus | In distribution | |
| SE-300B | In distribution | |
| SL18A | In distribution | |
| SL12A | In distribution | |
| SE-301 | In distribution | |
| SE-300A | In distribution | |
| ECG-12 B | In distribution | |
| iSE-1810 | In distribution | |
| iSE-1210 | In distribution | |
| SL6A | In distribution | |
| SE-1201 | In distribution | |
| SE-6 | In distribution | |
| ECG-6 Pro | In distribution | |
| SE-18 | In distribution | |
| ECG-3F Plus | In distribution | |
| ECG-3F | In distribution | |
| SE-1200Pro | In distribution | |
| SE-3 | In distribution | |
| ECG-3 Plus | In distribution | |
| ECG-6 Plus | In distribution | |
| SE-1202 | In distribution | |
| ECG-6 | In distribution | |
| ECG-1200 | In distribution | |
| SE-3 | In distribution | |
| SE-12 Express | 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 |
| 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 |
| ELI 280 | Mortara Instrument, Inc. | 41 |
| 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 |
|---|---|
| K252463 | 2026-07-02 |
| K222902 | 2023-07-28 |
| K212278 | 2022-04-07 |
| K210140 | 2021-10-01 |
| K171942 | 2018-01-24 |
| K171943 | 2017-09-25 |
| K170995 | 2017-06-02 |
| K160876 | 2017-02-15 |
| K161302 | 2016-07-01 |
| K152427 | 2016-02-05 |
| K131503 | 2014-02-25 |
| K131819 | 2013-11-22 |
| K120188 | 2012-03-16 |
| K102854 | 2010-12-03 |
| K102830 | 2010-12-02 |
| K093869 | 2010-04-01 |
| K092010 | 2009-10-22 |
| K091513 | 2009-07-24 |
| K090367 | 2009-06-03 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-09-10 | Not classified | Vendor change control | The 3 leads of the cable, RL, LA and LL were labeled in wrong sequence. The left arm (LA) is mislabeled as right leg (RL). The left leg (LL) is mislabeled as left arm (LA). The right leg (RL) is mislabeled as left leg (LL). There have bee | 615 Ccables | 2011-10-13 |
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.