K905274

Substantially Equivalent

VITALMAX 2100/2200

Applicant
Pace Tech, Inc.
Product code
DRT
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Clearwater, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT
Death
4
Total
4

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.