QKY — Decontamination Systems For N95 Respirators Class N
FDA product code QKY covers "Decontamination Systems For N95 Respirators", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QKY
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Unknown
- Implant
- No
Definition
Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency.