Wearable Automated External Defibrillator

MVK · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: MVK
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: CV
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: Y
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 10

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown