510(k) K243965
K243965 is an FDA 510(k) premarket notification submitted by Nerv Technology Inc. (D.B.A.) Fluidai Medical for the device "Origin". The FDA issued a decision of Substantially Equivalent on August 21, 2025. The device falls under product code SFO (Electrode Measurement, Drain Effluent Ph), a Class II device regulated under 21 CFR 862.1120.
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