K232512
- 510(k) number
- K232512
- Device name
- Masimo W1
- Applicant
- Masimo Corporation CA · US
- Product code
- DPS — Electrocardiograph
- Decision date
- 2023-11-17
- Date received
- 2023-08-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232512.pdf
Official FDA record: K232512
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.