K211498
- 510(k) number
- K211498
- Device name
- Nonin OTC Pulse Oximeter Model 3250
- Applicant
- Nonin Medical, Inc. MN · US
- Product code
- OLK — Pulse Oximeter For Over-The-Counter Use
- Decision date
- 2024-11-13
- Date received
- 2021-05-14
- 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: K211498.pdf
Official FDA record: K211498
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.