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

Acute Coronary Syndrome Event Detector

Unknown
FDA source (opens on fda.gov)

QBI is the FDA product code for Acute Coronary Syndrome Event Detector, a class III device type. FDA's definition for this code reads: "Detect Acute Coronary Syndrome events and prompt the patient to seek medical attention". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
QBI
Device name
Acute Coronary Syndrome Event Detector
FDA definition
Detect Acute Coronary Syndrome events and prompt the patient to seek medical attention.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code