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FDA 510(k)

Elfor-L

K-Number: K243852 · 2025-04-14

ApplicantElfi-Tech , Ltd.
Decision Date2025-04-14
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Elfor-L is a medical device manufactured by Elfi-Tech , Ltd.. It received FDA 510(k) clearance on 2025-04-14 under approval number K243852. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elfor-L?

Elfor-L is a medical device that received FDA 510(k) clearance on 2025-04-14. It is manufactured by Elfi-Tech , Ltd.. The 510(k) number is K243852.

When was Elfor-L approved by the FDA?

Elfor-L received FDA 510(k) clearance on 2025-04-14, under approval number K243852.

What company makes Elfor-L?

Elfor-L is manufactured by Elfi-Tech , Ltd..

What is the FDA product code for Elfor-L?

The FDA product code for Elfor-L is DPW.

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Official Source

View on FDA Database →

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

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