510(k) K230987 ยท BZR Mixer, Breathing Gases, Anesthesia Inhalation
FlowStar Analog Mixer Flowmeter
| Applicant | Baldus Sedation GmbH & Co. KG, Bendorf, DE |
| Decision | Substantially Equivalent, Sep 14, 2023 |
| Received | Apr 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230987
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.