Sterilizer Automated Loading System

PEC · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6880

Classification

FDA Product Code: PEC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.6880
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown