MVK — Wearable Automated External Defibrillator Class III
FDA product code MVK covers "Wearable Automated External Defibrillator", a Class III medical device. Submissions are reviewed by the Unknown panel.
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.