Product code QKY
- Device name
- Decontamination Systems For N95 Respirators
- Medical specialty
- Unknown
- Device class
- N
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency.
- Source
- FDA openFDA device classification dataset