Product code OZW

Device name

Ingestible Event Marker

Medical specialty

General Hospital

Device class

2

Regulation number

880.6305

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device

Source

FDA openFDA device classification dataset