Cardio Q50, Cardio Q70
The Cardio Q50 and Cardio Q70 record twelve-lead ECG signals and provide waveforms and interpretive analysis for professional review. They also perform spirometry, measuring respiratory…
The Cardio Q50 and Cardio Q70 record twelve-lead ECG signals and provide waveforms and interpretive analysis for professional review. They also perform spirometry, measuring respiratory parameters such as forced vital capacity and forced expiratory volume, with results stored, displayed, transferred or printed.
The ECG interpretation requires confirmation by a qualified medical professional alongside other clinical information. ECG age limits depend on the selected algorithm: the Bionet algorithm is for ages three and older, while the Glasgow algorithm includes all ages. Spirometry is for adults and children aged five or older.
Clinical Workflow
Trained personnel use the prescription equipment in healthcare facilities under licensed practitioner supervision. Records can be sent to a computer for file management, with optional hospital-information-system exchange and an optional internal battery pack.
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 | Bionet Co., Ltd., South Korea |
|---|---|
| FDA product code | DPS |
| Device type | Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2340 |
| Establishment | Manufacturer |
| 510(k) | K231160 |
| Record published | 2026-05-26 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Cardio Q50 | In distribution | |
| Cardio Q70 | 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 |
| Electrocardiograph | Edan Instruments, Inc. | 38 |
| Q-Stress | Mortara Instrument, Inc. | 25 |
| XScribe | Mortara Instrument, Inc. | 22 |
Showing 12 of 177. All products under Electrocardiograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231160 | 2023-12-15 |
| K231150 | 2023-11-09 |
| K220535 | 2022-11-15 |
| K113306 | 2012-07-16 |
| K102767 | 2011-06-03 |
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.