K970074

Substantially Equivalent

STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)

Applicant: Hill-Rom, Inc.
Product code: FMT
Advisory panel: General Hospital
Date received: 1997-01-08
Decision date: 1997-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Batesville, IN, US

Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.