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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode Measurement, Drain Effluent Ph
510(k) Number K243965
Device Name Origin™
Applicant
NERv Technology Inc. (D.B.A.) FluidAI Medical
809 Wellington Street North
Unit 2
Kitchener,  CA N2H5L6
Applicant Contact Mariam Al-Lami
Correspondent
NERv Technology Inc. (D.B.A.) FluidAI Medical
809 Wellington Street North
Unit 2
Kitchener,  CA N2H5L6
Correspondent Contact Mariam Al-Lami
Regulation Number862.1120
Classification Product Code
SFO  
Date Received12/23/2024
Decision Date 08/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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