FORE-SIGHT ELITE Module Tissue Oximeter— 510(k) K180003
Substantially EquivalentCas Medical Systems, Inc.
FDA 510(k) clearance K180003 for FORE-SIGHT ELITE Module Tissue Oximeter, Substantially Equivalent on 2018-05-10. Applicant: Cas Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cas Medical Systems, Inc.
- 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
- Branford, CT, US
Recent devices under product code MUD
view allMore clearances from Cas Medical Systems, Inc.
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 K180003
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 K180003.
Data sourced from openFDA. This site is unofficial and independent of the FDA.