QXJ — Whole Room Microbial Reduction Device Class II
FDA product code QXJ covers "Whole Room Microbial Reduction Device", a Class II medical device regulated under 21 CFR 880.6510. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QXJ
- Device Class
- Class II
- Regulation Number
- 880.6510
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.