K233827
- 510(k) number
- K233827
- Device name
- OxiWear
- Applicant
- Oxiwear, Inc. VA · US
- Product code
- DQA — Oximeter
- Decision date
- 2024-08-28
- Date received
- 2023-12-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K233827.pdf
Official FDA record: K233827
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.