PHOENIX INFANT RADIANT WARMER, MODEL 100NWS— 510(k) K033040

Substantially Equivalent

International Hospital Supply Co.

FDA 510(k) clearance K033040 for PHOENIX INFANT RADIANT WARMER, MODEL 100NWS, Substantially Equivalent on 2003-12-17. Applicant: International Hospital Supply Co..

Clearance details

Applicant: International Hospital Supply Co.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 2003-09-29
Decision date: 2003-12-17
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Amsterdam, NL

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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.