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U.S. Department of Health and Human Services

Product Classification

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Device monitor, blood-flow, cerebral, thermal diffusion
Review Panel Neurology
Product CodeLME
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NNDB)
Submission Type Contact ODE
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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