STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)— 510(k) K970074

Substantially Equivalent

Hill-Rom, Inc.

FDA 510(k) clearance K970074 for STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D), Substantially Equivalent on 1997-04-03. Applicant: Hill-Rom, Inc..

Clearance details

Applicant: Hill-Rom, Inc.
Product code: 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

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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.