K921487

Substantially Equivalent

MARQUETTE SERIES 360 DEFIBRILLATOR

Applicant
Marquette Electronics, Inc.
Product code
LDD
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Milwaukee, WI, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code LDD

product code LDD
Death
38
Malfunction
522
Total
560

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.