DeviceClearance

K972115

Substantially Equivalent

VOLKER HOSPITAL BED, MODEL K960

Applicant
Volker Healthcare, Inc.
Product code
FNL
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Great Neck,, NY, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FNL

product code FNL
Death
64
Injury
728
Malfunction
10,825
Other
9
Total
11,626

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.