PEC

Sterilizer Automated Loading System

Product code: PEC
Device name: Sterilizer Automated Loading System
Device class: Class 2
21 CFR: 21 CFR 880.6880
Medical specialty: General Hospital
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PEC

Classification and pathway per current FDA publications. Data from openFDA (CC0).