QXJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Whole Room Microbial Reduction Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6510
- Medical specialty
- General Hospital
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Helios+ UV-C System (K242604) | Preventamed Technologies, Inc. Dba Surfacide Manufacturing | 2025-05-27 |
| LightStrike+ (MXSUV1-SL and MXSUV1-FT) (DEN230007) | Xenex Disinfection Services, Inc. | 2023-09-01 |
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