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FDA 510(k)

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

K-Number: K250459 · 2025-04-18

Decision Date2025-04-18
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution is the device name listed in this FDA 510(k) record. The listed applicant is Technoflex Sas.. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K250459. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution?

DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is Technoflex Sas.. The 510(k) number is K250459.

When did DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution receive FDA 510(k) clearance?

DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution received FDA 510(k) clearance on 2025-04-18, under 510(k) number K250459.

Who is the listed applicant for DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution?

The FDA 510(k) record lists Technoflex Sas. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution?

The FDA product code for DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution is KPE.

Related Devices (Code: KPE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.