510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MVKClass III

Wearable Automated External Defibrillator

Unknown
FDA source (opens on fda.gov)

MVK is the FDA product code for Wearable Automated External Defibrillator, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and 5 recalls.

Classification record

Product code
MVK
Device name
Wearable Automated External Defibrillator
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
5

Companies listing this code with FDA

Companies whose registered establishments list this code