K871449

Substantially Equivalent

ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG

Applicant
Pa Medical Corp.
Product code
KPE
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Columbia, TN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KPE

product code KPE
Malfunction
1,000
Other
1
Total
1,001

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.