MEDIX PC-305 NEONATAL INCUBATOR— 510(k) K920049

Name: FDA 510(k) clearance K920049
Creator: U.S. Food and Drug Administration
Published: 1993-05-21

Substantially Equivalent

Medix I.C.S.A.

FDA 510(k) clearance K920049 for MEDIX PC-305 NEONATAL INCUBATOR, Substantially Equivalent on 1993-05-21. Applicant: Medix I.C.S.A.. Device class: 2.

Clearance details

Applicant: Medix I.C.S.A.
Product code: Code FMZ
Device class: Class 2
Regulation: 21 CFR 880.5400
Advisory panel: General Hospital
Date received: 1992-01-06
Decision date: 1993-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Martin, Buenos Aires, AR

Download summary PDF View on FDA.gov ↗

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More clearances from Medix I.C.S.A.

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K103735 — MEDILED MINI2011-08-15
K083179 — MEDILED PHOTOTHERAPY LAMP2009-02-27
K070291 — MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX2007-09-21
K931529 — INFANT WARMER1994-03-11
K931965 — MEDIX PHOTOTHERAPY LAMP1993-12-09

Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

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.