K251585
- 510(k) number
- K251585
- Device name
- Profoject Enteral Feeding Syringe
- Applicant
- CMT Health PTE., Ltd. SG
- Product code
- PNR — Enteral Syringes With Enteral Specific Connectors
- Decision date
- 2025-07-18
- Date received
- 2025-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K251585.pdf
Official FDA record: K251585
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.