MVK — Wearable Automated External Defibrillator Class III

FDA Device Classification

Classification Details

Product Code: MVK
Device Class: Class III
Regulation Number
Submission Type
Review Panel: CV
Medical Specialty: Unknown
Implant: No

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.