Product code QXJ
- Device name
- Whole Room Microbial Reduction Device
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6510
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset