CRITICAL CARE HOSPITAL BED (ICU/CCU)— 510(k) K915437

Substantially Equivalent

Hill-Rom, Inc.

FDA 510(k) clearance K915437 for CRITICAL CARE HOSPITAL BED (ICU/CCU), Substantially Equivalent on 1992-06-11. Applicant: Hill-Rom, Inc..

Clearance details

Applicant: Hill-Rom, Inc.
Product code: Code FNL
Advisory panel: General Hospital
Date received: 1991-11-26
Decision date: 1992-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Batesville, TN, 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.