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U.S. Department of Health and Human Services

Product Classification

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Device chair, pneumoencephalographic
Regulation Description Pneumoencephalographic chair.
Regulation Medical Specialty Radiology
Review Panel Radiology
Product CodeHBK
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 892.1820
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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