Product Classification

• 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 Code: QXJ
• Premarket Review: Office of Surgical and Infection Control Devices (OHT4); 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