DeviceClearance

K163255

Substantially Equivalent

CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor

Applicant
Caretaker Medical, LLC
Product code
DXN
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Charlottesville, VA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN
Death
3
Injury
169
Malfunction
1,019
Other
2
Total
1,193

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.