Whole Room Microbial Reduction Device

QXJ · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6510

Classification

FDA Product Code: QXJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.6510
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A whole room microbial reduction device is a medical device to be used to reduce microbial load on medical device surfaces following cleaning and disinfection.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 2

Source

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