K232385
- 510(k) number
- K232385
- Device name
- OxiplexTS200
- Applicant
- Iss Medical, Inc. IL · US
- Product code
- MUD — Oximeter, Tissue Saturation
- Decision date
- 2024-03-01
- Date received
- 2023-08-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K232385.pdf
Official FDA record: K232385
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.