Decision Date2025-04-14
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Elfor-L is the device name listed in this FDA 510(k) record. The listed applicant is Elfi-Tech , Ltd.. It received FDA 510(k) clearance on 2025-04-14 under 510(k) 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. The listed applicant is Elfi-Tech , Ltd.. The 510(k) number is K243852.
When did Elfor-L receive FDA 510(k) clearance?
Elfor-L received FDA 510(k) clearance on 2025-04-14, under 510(k) number K243852.
Who is the listed applicant for Elfor-L?
The FDA 510(k) record lists Elfi-Tech , Ltd. as the applicant. This does not by itself establish the device manufacturer.
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.