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U.S. Department of Health and Human Services

Product Classification
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Device monitor, alpha
Regulation Description Alpha monitor.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGXS
Submission Type 510(k)
Regulation Number 882.1610
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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