IKO — Hammer, Reflex, Powered Class II

FDA Device Classification

FDA product code IKO covers "Hammer, Reflex, Powered", a Class II medical device regulated under 21 CFR 890.1450. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
IKO
Device Class
Class II
Regulation Number
890.1450
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K904113medical dynamicsOPERATIVE RECORDING CAMERAOctober 30, 1990