DeviceClearance

K153335

Substantially Equivalent

AlertWatch: OR

Applicant
Alertwatch, LLC
Product code
MWI
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ann Arbor, MI, 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.