K232111
- 510(k) number
- K232111
- Device name
- NeoBeat, NeoBeat Mini
- Applicant
- Laerdal Medical AS NO
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2024-06-25
- Date received
- 2023-07-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232111.pdf
Official FDA record: K232111
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.