K860372

Substantially Equivalent

FAST FLOW XX (AQUEOUS SOLUTION FILTER)

Applicant
Healthtek, Inc.
Product code
FPB
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Nevada City, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FPB

product code FPB
Other
1
Total
1

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.