Disinfector, Medical Devices
The medical device disinfector is a general hospital device used to apply chemical disinfecting agents to reusable medical instruments and equipment surfaces to eliminate or reduce pathogenic microorganisms, as part of the reprocessing cycle. It is classified as FDA Class II under 21 CFR 880.6992 within the General Hospital specialty, requiring 510(k) premarket clearance. The product code is MEC and the device is not implanted. Full GMP compliance is required.
Basic Information
- Product Code
- MEC
- Device Class
- FDA class 2
- Regulation Number
- 880.6992
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
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 41 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.