MUD — Oximeter, Tissue Saturation Class II
FDA Device Classification
Classification Details
- Product Code
- MUD
- Device Class
- Class II
- Regulation Number
- 870.2700
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243324 | masimo corporation | Masimo O3 Regional Oximeter | July 17, 2025 |
| K250519 | vioptix | Lap.Ox Laparoscopic Tissue Oximeter | June 26, 2025 |
| K240596 | edwards lifesciences | Cerebral Autoregulation Index (CAI) Algorithm | October 16, 2024 |
| K241393 | odi medical | ODI-Tech | August 30, 2024 |
| K240601 | kent imaging | SnapshotNIR model KD205 | April 2, 2024 |
| K232385 | iss medical | OxiplexTS200 | March 1, 2024 |
| K233488 | vioptix | Intra.Ox 2.0 Handheld Tissue Oximeter | February 28, 2024 |
| K230612 | edwards lifesciences | Edwards Algorithm for Measurement of Blood Hemoglobin | November 17, 2023 |
| K223651 | edwards lifesciences | Cerebral Adaptive Index (CAI) Algorithm | May 26, 2023 |
| K214072 | masimo corporation | Masimo O3 Regional Oximeter System | May 6, 2022 |
| K221010 | vioptix | Intra.Ox 2.0 Handheld Tissue Oximeter | May 3, 2022 |
| K211561 | covidien | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional | December 5, 2021 |
| K203490 | edwards lifesciences | FORE-SIGHT ELITE Absolute Tissue Oximeter | February 10, 2021 |
| K201976 | kent imaging | SnapshotNIR | November 10, 2020 |
| K201432 | masimo corporation | Masimo O3 Regional Oximeter System | August 29, 2020 |
| K190334 | mimosa diagnostics | MIMOSA Imager | November 1, 2019 |
| K190270 | cas medical systems | FORE-SIGHT ELITE Tissue Oximeter Module | October 21, 2019 |
| K192322 | spectros corporation | T-Stat 2.0 Microvascular Tissue Oximeter | September 23, 2019 |
| K191676 | vioptix | Intra.Ox 2.0 Handheld Tissue Oximeter | September 16, 2019 |
| K182429 | masimo corporation | Masimo O3 Regional Oximeter System | June 7, 2019 |