Product code QXJ
- Device name
- Whole Room Microbial Reduction Device
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6510
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K242604 | Helios+ UV-C System | Preventamed Technologies, Inc. Dba Surfacide Manufacturing | 2025-05-27 |
| DEN230007 | LightStrike+ (MXSUV1-SL and MXSUV1-FT) | Xenex Disinfection Services, Inc. | 2023-09-01 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00814122020163 | LightStrike+ | Xenex Disinfection Services Inc. | 2023-11-06 |
| 00814122020170 | LightStrike+ | Xenex Disinfection Services Inc. | 2023-11-06 |