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U.S. Department of Health and Human Services

Product Classification

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Device chronaximeter
Regulation Description Chronaximeter.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeIKP
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 890.1225
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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