LRI — Ph Meter For Dialysis Hydrogen Ion Concentration Class II

FDA Device Classification

FDA product code LRI covers "Ph Meter For Dialysis Hydrogen Ion Concentration", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
LRI
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K870811mesa medicalMODEL 102 PH METERMarch 24, 1987