Atlas FDA

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.
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RecordFirmDate
Helios+ UV-C System (K242604)Preventamed Technologies, Inc. Dba Surfacide Manufacturing2025-05-27
LightStrike+ (MXSUV1-SL and MXSUV1-FT) (DEN230007)Xenex Disinfection Services, Inc.2023-09-01

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