FDA 510(k) K242604, Helios+ UV-C System, by Preventamed Technologies, Inc. Dba Surfacide Manufacturing
FDA 510(k) K242604, Helios+ UV-C System, by Preventamed Technologies, Inc. Dba Surfacide Manufacturing
| 510(k) Number | K242604 |
| Device Classification Name | Whole Room Microbial Reduction Device |
| Device Name | Helios+ UV-C System |
| Applicant | Preventamed Technologies, Inc. Dba Surfacide Manufacturing W226n918 Northmound Dr., Suite 300 Waukesha, WI 53186 |
| Classification Product Code | QXJ |
| Date Received | 08/30/2024 |
| Decision Date | 05/27/2025 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | General Hospital |
| 510k Review Panel | General Hospital |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 8492 |
| Redacted Pages | 7199 |
| Unredacted Pages | 1293 |
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