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U.S. Department of Health and Human Services

Product Classification

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Device chamber, reverse isolation, patient care
Regulation Description Patient care reverse isolation chamber.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFRR
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control Devices (DHT4C)
Submission Type 510(k)
Regulation Number 880.5450
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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