SFO — Electrode Measurement, Drain Effluent Ph Class II

FDA Device Classification

FDA product code SFO covers "Electrode Measurement, Drain Effluent Ph", a Class II medical device regulated under 21 CFR 862.1120. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
SFO
Device Class
Class II
Regulation Number
862.1120
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Definition

Measurement of drain effluent pH

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243965nerv technology inc. (d.b.a.) fluidai medicalOrigin™August 21, 2025