K230987
- 510(k) number
- K230987
- Device name
- FlowStar Analog Mixer Flowmeter
- Applicant
- Baldus Sedation GmbH & Co. KG DE
- Product code
- BZR — Mixer, Breathing Gases, Anesthesia Inhalation
- Decision date
- 2023-09-14
- Date received
- 2023-04-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K230987.pdf
Official FDA record: K230987
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.