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..
Clearance details
- Applicant
- Cas Medical Systems, Inc.
- Product code
- Code MUD
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branford, CT, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.