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U.S. Department of Health and Human Services

Product Classification

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Device rheoencephalograph
Definition Call for PMAs to be filed by 12/26/96 per 61 FR 50708 on 9/27/96
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGZN
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type PMA
Regulation Number 882.1825
Device Class 3
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
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