MEC — Disinfector, Medical Devices Class II

FDA Device Classification

FDA product code MEC covers "Disinfector, Medical Devices", a Class II medical device regulated under 21 CFR 880.6992. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MEC
Device Class
Class II
Regulation Number
880.6992
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K081094olympic medicalOLYMPIC PASTEURMATIC, MODELS 3000 AND 3500June 20, 2008
K911120hamo usaDECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21February 3, 1994