K230612
- 510(k) number
- K230612
- Device name
- Edwards Algorithm for Measurement of Blood Hemoglobin
- Applicant
- Edwards Lifesciences, LLC CA · US
- Product code
- MUD — Oximeter, Tissue Saturation
- Decision date
- 2023-11-17
- Date received
- 2023-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K230612.pdf
Official FDA record: K230612
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.