DeviceClearance

K082027

Substantially Equivalent

FLU-ADMIN, MODELS 60150, 60150C, 60151C, 60153C, 60160

Applicant
Genesis Bps, LLC
Product code
FPA
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hackensack, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA
Death
95
Injury
14,421
Malfunction
125,815
Other
30
Total
140,361

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.