FORE-SIGHT ELITE Absolute Tissue Oximeter— 510(k) K203490
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K203490 for FORE-SIGHT ELITE Absolute Tissue Oximeter, Substantially Equivalent on 2021-02-10. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code MUD
- Device class
- Class 2
- Regulation
- 21 CFR 870.2700
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code MUD
view allMore clearances from Edwards Lifesciences, LLC
view allAdverse events under product code MUD
product code MUD- Malfunction
- 467
- Total
- 467
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K203490
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203490.
Data sourced from openFDA. This site is unofficial and independent of the FDA.