FES — Recorder, External, Pressure, Amplifier & Transducer Class II

FDA Device Classification

FDA product code FES covers "Recorder, External, Pressure, Amplifier & Transducer", a Class II medical device regulated under 21 CFR 876.1725. Submissions are reviewed by the Gastroenterology, Urology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
FES
Device Class
Class II
Regulation Number
876.1725
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K890284ferguson medicalURODEC 500May 30, 1989
K801757medical measurementsMMI/GAELTEC CATHETER TIP PRESS. TRANSDUAugust 27, 1980