QBI — Acute Coronary Syndrome Event Detector Class III

FDA Device Classification

FDA product code QBI covers "Acute Coronary Syndrome Event Detector", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.

Classification Details

Product Code
QBI
Device Class
Class III
Regulation Number
Submission Type
Review Panel
CV
Medical Specialty
Unknown
Implant
Yes

Definition

Detect Acute Coronary Syndrome events and prompt the patient to seek medical attention.