DeviceClearance

K934644

Substantially Equivalent

K3 SYSTEM

Applicant
Astro-Med, Inc.
Product code
DRT
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Warwick, RI, 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.