3 catalogue numbers from Adapter for 7 Leadwires, 150 cm, listed by Getemed Medizin- UND Informationstechnik AG, Germany, under Recorder, Magnetic Tape, Medical. 4 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for ECG Trunk Cable for CM 3000 Series | Listed by | Getemed Medizin- UND Informationstechnik AG, Germany |
| FDA product code | DSH |
| Device type | Recorder, Magnetic Tape, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K022540 |
| Record published | 2016-09-21 |
| Record revised | 2024-06-06 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 90 % RH; 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.