K243354
- 510(k) number
- K243354
- Device name
- Remunity System
- Applicant
- Deka Research & Development Corp. NH · US
- Product code
- QJY — Infusion Pump, Drug Specific, Pharmacy-Filled
- Decision date
- 2024-11-27
- Date received
- 2024-10-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243354.pdf
Official FDA record: K243354
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.