K234021
- 510(k) number
- K234021
- Device name
- Masimo Stork
- Applicant
- Masimo Corporation CA · US
- Product code
- QYU — Infant Pulse Rate And Oxygen Saturation Monitor For
- Decision date
- 2024-05-03
- Date received
- 2023-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K234021.pdf
Official FDA record: K234021
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.