QXJ · Whole Room Microbial Reduction Device
General Hospital · 21 CFR 880.6510 · Class 2
Overview
| Product Code | QXJ |
|---|---|
| Device Name | Whole Room Microbial Reduction Device |
| Regulation | 21 CFR 880.6510 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242604 | Helios+ UV-C System | Preventamed Technologies, Inc. Dba Surfacide Manufacturing | May 27, 2025 | SESE |
| DEN230007 | LightStrike+ (MXSUV1-SL and MXSUV1-FT) | Xenex Disinfection Services, Inc. | Sep 1, 2023 | DENG |
Top Applicants
- Preventamed Technologies, Inc. Dba Surfacide Manufacturing — 1 clearance
- Xenex Disinfection Services, Inc. — 1 clearance
