Remunity System— 510(k) K243354
Substantially EquivalentDeka Research & Development Corp.
FDA 510(k) clearance K243354 for Remunity System, Substantially Equivalent on 2024-11-27. Applicant: Deka Research & Development Corp..
Clearance details
- Applicant
- Deka Research & Development Corp.
- Product code
- Code QJY
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Manchester, NH, US
Adverse events under product code QJY
product code QJY- Death
- 4
- Other
- 1
- Total
- 5
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.