Data / Medical devices / Germany / Getemed Medizin- Und Informationstechnik AG
Getemed Medizin- Und Informationstechnik AG: FDA-registered device maker in TELTOW Brandenburg, Germany, 4 510(k) clearances
Getemed Medizin- Und Informationstechnik AG is registered with the FDA (registration 3004006614) in TELTOW Brandenburg, Germany. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 24, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004006614
- Address
- Oderstrasse 77, TELTOW Brandenburg, Germany, 14513
- Owner or operator
- GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG (9052369)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 5, 2007
- Registered through
- 2026
- Brand names listed
- CardioDay Holter Evaluation Software, CardioDay V2.5, CardioDay v2.6, CardioDay v2.7, CardioMem CM 3000-12 BT, CardioMem CM 3000-12 BT / SEER 12, Holter Recorder, Product Code MWJ
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 24, 2017 | K162023 | CardioDay V2.5 | DQK | Substantially Equivalent | Getemed Medizin- Und Informationstechnik AG | accessdata.fda.gov |
| July 26, 2013 | K130785 | SEER 1000 | MWJ | Substantially Equivalent | Getemed Medizin- Und Informationstechnik AG | accessdata.fda.gov |
| March 28, 2013 | K122272 | CARDIOMEM | MWJ | Substantially Equivalent | Getemed Medizin- Und Informationstechnik AG | accessdata.fda.gov |
| May 30, 2007 | K063042 | CARDIOMEM CM 3000-12BT | MWJ | Substantially Equivalent | Getemed Medizin- Und Informationstechnik AG | accessdata.fda.gov |
Compare with other makers
- All makers of Computer, Diagnostic, Programmable
- All makers of Electrocardiograph, Ambulatory (Without Analysis)
Updated March 24, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.