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510(k) K243965

Origin by Nerv Technology Inc. (D.B.A.) Fluidai Medical — Product Code SFO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 21, 2025
Date Received: December 23, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Electrode Measurement, Drain Effluent Ph
Device Class: Class II
Regulation Number: 862.1120
Review Panel: CH
Submission Type

Measurement of drain effluent pH