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U.S. Department of Health and Human Services

Product Classification

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Device whole room microbial reduction device
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.
Physical State Device remotely operated to promote microbial log reduction on critical, semicritical, and non-critical medical devices surfaces.
Technical Method Microbial reduction on surfaces and/or air using a germicidal device.
Target Area Unoccupied rooms
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQXJ
Premarket Review Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 880.6510
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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