Data / Medical devices / Germany / Bosch Healthcare Solutions GMBH
Bosch Healthcare Solutions GMBH: FDA-registered device maker in Waiblingen Baden-Wurttemberg, Germany, 1 510(k) clearance
Bosch Healthcare Solutions GMBH is registered with the FDA (registration 3001082393) in Waiblingen Baden-Wurttemberg, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 22, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001082393
- Address
- Alte Bundesstrasse 50, Waiblingen Baden-Wurttemberg, Germany, 71332
- Owner or operator
- Bosch Healthcare Solutions GmbH (10090281)
- Roles
- Manufacturer
- First device listed
- March 7, 2024
- Registered through
- 2026
- Brand names listed
- Vivatmo pro
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Test, Breath Nitric Oxide | MXA | 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 |
|---|---|---|---|---|---|---|
| February 22, 2024 | K233775 | Vivatmo pro | MXA | Substantially Equivalent | Bosch Healthcare Solutions GmbH | accessdata.fda.gov |
Compare with other makers
Updated February 22, 2024. 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.