INFANT WARMER— 510(k) K931529

Substantially Equivalent

Medix I.C.S.A.

FDA 510(k) clearance K931529 for INFANT WARMER, Substantially Equivalent on 1994-03-11. Applicant: Medix I.C.S.A..

Clearance details

Applicant: Medix I.C.S.A.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1993-03-26
Decision date: 1994-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Martin, Buenos Aires, AR

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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.