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U.S. Department of Health and Human Services

Product Classification
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Device plethysmograph, ocular
Regulation Description Ocular plethysmograph.
Definition PMAs to be filed by 9/21/04 (69 FR 34920 (6/23/04))
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeJXF
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type PMA
Regulation Number 882.1790
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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