K241393
- 510(k) number
- K241393
- Device name
- ODI-Tech
- Applicant
- Odi Medical AS NO
- Product code
- MUD — Oximeter, Tissue Saturation
- Decision date
- 2024-08-30
- Date received
- 2024-05-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K241393
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.