K895859

Substantially Equivalent

CONTAIN(TM)

Applicant
Arbor Technologies, Inc.
Product code
GCX
Advisory panel
General Hospital
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 GCX

product code GCX
Death
9
Malfunction
592
Other
2
Total
603

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.