The CardioMem CM 4000 and CM 4000 B digital Holter recorders are intended to continuously record ECG data. The recorders per-form no cardiac analysis by themselves and are intended to be…
The CardioMem CM 4000 and CM 4000 B digital Holter recorders are intended to continuously record ECG data. The recorders per-form no cardiac analysis by themselves and are intended to be used with an ECG analysis software package. The recorded data are down-loaded to a PC for analysis and subsequent evaluation by a trained physician or health care professional.
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for CardioMem | Listed by | Getemed Medizin- UND Informationstechnik AG, Germany |
| FDA product code | MWJ |
| Device type | Electrocardiograph, Ambulatory (Without Analysis) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K122272 |
| Record published | 2026-05-01 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -25 to 70 °C |
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.