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510(k) K243852

Elfor-L by Elfi-Tech , Ltd. — Product Code DPW

K243852 is an FDA 510(k) premarket notification submitted by Elfi-Tech , Ltd. for the device "Elfor-L". The FDA issued a decision of Substantially Equivalent on April 14, 2025. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2025
Date Received
December 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

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FDA data resources