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U.S. Department of Health and Human Services

Product Classification

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Device wearable automated external defibrillator
Definition The device is an automatic external defibrillator which monitors and treats a patient for ventricular defibrillation.Device is intended to be worn in home or in hospital settings as prescribed and overseen by a physician.
Review Panel Cardiovascular
Product CodeMVK
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type PMA
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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