Whole Room Microbial Reduction Device
The whole room microbial reduction device (product code QXJ) is a Class 2 General Hospital device (regulation 880.6510) used to reduce the microbial load on medical device surfaces following cleaning and disinfection in a whole-room format. It requires 510(k) clearance. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QXJ
- Device Class
- FDA class 2
- Regulation Number
- 880.6510
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.