Holter ECG and ABP System
The Holter ECG and ABP System reviews ambulatory ECG and blood-pressure recordings captured by compatible recorders. It is Windows-based software for retrospective analysis, editing,…
The Holter ECG and ABP System reviews ambulatory ECG and blood-pressure recordings captured by compatible recorders. It is Windows-based software for retrospective analysis, editing, display and reporting in hospitals and healthcare facilities by physicians or trained professionals.
The software detects and classifies QRS complexes, identifies possible arrhythmias and measures ST segments, while producing trends and summary tables. Blood-pressure data is displayed and summarised statistically. Automated findings and unconfirmed reports are advisory and require professional review.
Age and Monitoring Limits
Blood-pressure analysis and arrhythmia detection are intended for patients older than 12. ECG analysis can include adults and children. The system is not intended for real-time monitoring or alarms.
Who Else Makes It
Concentrated in Guangdong (7), Shanghai (2), Jiangsu (1). 4 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 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Dongguan Ergotron Precision Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd | Shenzhen | Guangdong | Manufacturer | 7 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
| Shenzhen Carewell Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Edan Instruments, Inc., China |
|---|---|
| FDA product code | DQK |
| Device type | Computer, Diagnostic, Programmable |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1425 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K251591 |
| Record published | 2026-03-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HolterABP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EnSite™ | St. Jude Medical | 177 |
| Computer, Diagnostic, Programmable | St. Jude Medical | 57 |
| MediGuide™ | St. Jude Medical | 41 |
| AcQMap | Acutus Medical, Inc. | 38 |
| WorkMate Claris™ | St. Jude Medical | 35 |
| iLab Ultrasound Imaging System | Boston Scientific Corporation | 32 |
| Rhythmia™ Mapping System | Boston Scientific Corporation | 31 |
| Sentinel | Spacelabs Healthcare (Washington), Inc | 28 |
| Rhythmia HDx™ | Boston Scientific Corporation | 26 |
| EnSite Precision™ | St. Jude Medical | 23 |
| PathfinderSL | Spacelabs Healthcare (Washington), Inc | 22 |
| Labsystem™ PRO | Boston Scientific Corporation | 19 |
Showing 12 of 228. All products under Computer, Diagnostic, Programmable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251591 | 2026-02-09 |
| K151787 | 2016-01-27 |
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.