510(k) K243965
- Device
- Origin™
- Applicant
- Nerv Technology Inc. (D.B.A.) Fluidai Medical
- 510(k) number
- K243965
- Product code
- SFO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-21
- Date received
- 2024-12-23
- Regulation
- 862.1120
- Classification name
- Electrode Measurement, Drain Effluent Ph
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Mariam Al-Lami
- Address
- 809 Wellington St. N. Unit 2 Kitchener CA N2H5L6 N2H5L6