510(k) K242604
- Device
- Helios+ UV-C System
- Applicant
- Preventamed Technologies, Inc. Dba Surfacide Manufacturing
- 510(k) number
- K242604
- Product code
- QXJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-27
- Date received
- 2024-08-30
- Regulation
- 880.6510
- Classification name
- Whole Room Microbial Reduction Device
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jeffry Veenhuis
- Address
- W226n918 Northmound Dr., Suite 300 Waukesha WI US 53186 53186
FDA Registration Numbers#
- 3013869012
- 3014531752
Source Documents#
Other 510(k) Records For Product Code QXJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230007 | LightStrike+ (MXSUV1-SL and MXSUV1-FT) | Xenex Disinfection Services, Inc. | 2023-09-01 |