DeviceClearance

K992638

Substantially Equivalent

DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400

Applicant
Critikon Company, LLC
Product code
MWI
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Tampa, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI
Death
16
Malfunction
963
Total
979

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.