K214115
- 510(k) number
- K214115
- Device name
- MightySat -OTC
- Applicant
- Masimo Corporation CA · US
- Product code
- OLK — Pulse Oximeter For Over-The-Counter Use
- Decision date
- 2024-01-31
- Date received
- 2021-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K214115.pdf
Official FDA record: K214115
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.