Data / Medical devices / Germany / Baldus Sedation GmbH & Co. KG
Baldus Sedation GmbH & Co. KG: FDA-registered device maker in Bendorf Rhineland-Palatinate, Germany, 2 510(k) clearances
Baldus Sedation GmbH & Co. KG is registered with the FDA (registration 3011780089) in Bendorf Rhineland-Palatinate, Germany. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 14, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011780089
- Address
- In der Langfuhr 32, Bendorf Rhineland-Palatinate, Germany, 56170
- Owner or operator
- Baldus Sedation GmbH & Co. KG (10062442)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 28, 2020
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Manufacturer | accessdata.fda.gov |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Manufacturer | accessdata.fda.gov |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 14, 2023 | K230987 | FlowStar Analog Mixer Flowmeter | BZR | Substantially Equivalent | Baldus Sedation GmbH & Co. KG | accessdata.fda.gov |
| July 28, 2023 | K222794 | FlowStar Touch Digital Mixer Flowmeter | BZR | Substantially Equivalent | Baldus Sedation GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Mask, Scavenging
- All makers of Mixer, Breathing Gases, Anesthesia Inhalation
- All makers of Connector, Airway (Extension)
- All makers of Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Updated September 14, 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.