K250459

DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution

510(k) number: K250459
Device name: DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
Applicant: Technoflex Sas. FR
Product code: KPE — Container, I.V.
Decision date: 2025-04-18
Date received: 2025-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

Also available from FDA: K250459.pdf

Official FDA record: K250459

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.