Data / Medical devices / Germany / DEHAS Medical Systems GmbH
DEHAS Medical Systems GmbH: FDA-registered device maker in Luebeck Schleswig-Holstein, Germany, 3 510(k) clearances
DEHAS Medical Systems GmbH is registered with the FDA (registration 3013156250) in Luebeck Schleswig-Holstein, Germany. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 23, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013156250
- Address
- Wesloer Strasse, Luebeck Schleswig-Holstein, Germany, 23568
- Owner or operator
- DEHAS Medical Systems GmbH (10043558)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 27, 2013
- Registered through
- 2026
- Brand names listed
- Flowmeter for PM2300er, Oxymixer Configuration, Oxymixer High Flow SET, Oxymixer Low Flow 15LPM, Oxymixer Low Flow SET, Oxymixer XL Low Flow, PM2100er Easymate 6, 6+6, PM2200 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | 1 | Manufacturer | accessdata.fda.gov |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | 2 | Manufacturer | accessdata.fda.gov |
| Regulator, Pressure, Gas Cylinder | CAN | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Unit, Liquid-Oxygen, Portable | BYJ | 2 | 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 |
|---|---|---|---|---|---|---|
| January 23, 2023 | K221494 | Quality Mix Blender, Oxymixer | BZR | Substantially Equivalent | Dehas Medical Systems GmbH | accessdata.fda.gov |
| April 21, 2011 | K103324 | PRECISION LIQUID OXYGEN SYSTEM | BYJ | Substantially Equivalent | Precision Medical, Inc. | accessdata.fda.gov |
| October 4, 2004 | K041122 | PRECISION LIQUID OXYGEN SYSTEM | BYJ | Substantially Equivalent | Precision Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Liquid-Oxygen, Portable
- All makers of Regulator, Pressure, Gas Cylinder
- All makers of Tubing, Pressure And Accessories
- All makers of Mixer, Breathing Gases, Anesthesia Inhalation
- All makers of Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Updated January 23, 2023. 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.