K241086
- 510(k) number
- K241086
- Device name
- Avidhrt Sense SpO2
- Applicant
- Avidhrt, Inc. MI · US
- Product code
- DQA — Oximeter
- Decision date
- 2025-05-09
- Date received
- 2024-04-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.6 MB · U.S. public domain
Also available from FDA: K241086.pdf
Official FDA record: K241086
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.