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U.S. Department of Health and Human Services

Product Classification

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Device air filter portable apparatus
Regulation Description Air-handling apparatus for a surgical operating room.
Definition The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.
Physical State A reusable mobile HEPA air filtration unit with a hose connecting to a disposable air delivery unit to be place at the surgical site.
Technical Method The system uses an air supply hose connected to nozzle design that is to be mounted, or applied to the incision drape in close proximity to the surgical site to provide direct air flow blowing over the surgical incision site that helps reduce the level of ambient airborne contamination.
Target Area Surgical site.
Regulation Medical Specialty General & Plastic Surgery
Review Panel General Hospital
Product CodeORC
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 878.5070
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible