K241736
- 510(k) number
- K241736
- Device name
- Remunity 2.0 Pump for Remodulin (treprostinil) Injection
- Applicant
- Deka Research and Development Corp. NH · US
- Product code
- FRN — Pump, Infusion
- Decision date
- 2025-01-16
- Date received
- 2024-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241736.pdf
Official FDA record: K241736
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.