FCP — Box, Battery, Pocket Class I

FDA Device Classification

FDA product code FCP covers "Box, Battery, Pocket", a Class I medical device regulated under 21 CFR 876.1500. 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
FCP
Device Class
Class I
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K891927lucas and rhea mfgTELEMETRY POWER PACK MODEL 2April 26, 1990
K881885dowit service coBATTERY PACKS (OTHER THAN CV)July 26, 1988