510(k) K242604
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 2025
- Date Received
- August 30, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Whole Room Microbial Reduction Device
- Device Class
- Class II
- Regulation Number
- 880.6510
- Review Panel
- HO
- Submission Type
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.