C3 Wave— 510(k) K143238
Substantially EquivalentMedcomp ( Medical Components)
FDA 510(k) clearance K143238 for C3 Wave, Substantially Equivalent on 2015-04-24. Applicant: Medcomp ( Medical Components).
Clearance details
- Applicant
- Medcomp ( Medical Components)
- Product code
- Code LJS
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Harleysville, PA, US
Adverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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.