QKY

Decontamination Systems For N95 Respirators

Product code: QKY
Device name: Decontamination Systems For N95 Respirators
Device class: Class N
Medical specialty: Unknown
Marketing pathway: EUA - Emergency Use Authorization

FDA classification definition

Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency.

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

Official FDA classification page: QKY

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