VOLKER HOSPITAL BED, MODEL K960— 510(k) K972115

Substantially Equivalent

Volker Healthcare, Inc.

FDA 510(k) clearance K972115 for VOLKER HOSPITAL BED, MODEL K960, Substantially Equivalent on 1997-08-29. Applicant: Volker Healthcare, Inc..

Clearance details

Applicant: Volker Healthcare, Inc.
Product code: Code FNL
Advisory panel: General Hospital
Date received: 1997-06-05
Decision date: 1997-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, NY, US

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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, 2020-01-01 through 2026-04-23. 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.