PEC — Sterilizer Automated Loading System Class II

FDA Device Classification

Classification Details

Product Code
PEC
Device Class
Class II
Regulation Number
880.6880
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Definition

Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K120532getinge sourcingGETINGE 633HC STEAM STERILIZER AIR GLIDE SYSTEMMay 2, 2013