QXQ — Respiratory Accessory Microbial Reduction Device. Class II
FDA product code QXQ covers "Respiratory Accessory Microbial Reduction Device.", a Class II medical device regulated under 21 CFR 880.6993. Submissions are reviewed by the General Hospital panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QXQ
- Device Class
- Class II
- Regulation Number
- 880.6993
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturers cleaning instructions.