DeviceClearance

Product code SFO— Clinical Chemistry

Origin

Classification name
Electrode Measurement, Drain Effluent Ph
Device class
Class 2
Regulation
21 CFR 862.1120
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

FDA classification definition

“Measurement of drain effluent pH”

— U.S. Food and Drug Administration, device classification record for product code SFO under 21 CFR 862.1120, via openFDA

Market context for product code SFO

FDA has cleared 1 device under product code SFO, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SFO

Recent clearances under product code SFO

Data sourced from openFDA. This site is unofficial and independent of the FDA.