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U.S. Department of Health and Human Services

Product Classification

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Device algesimeter, powered
Regulation Description Powered algesimeter.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeBSI
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type 510(k)
Regulation Number 868.1040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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