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510(k) K243852

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

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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