MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX— 510(k) K070291
Substantially EquivalentMedix I.C.S.A.
FDA 510(k) clearance K070291 for MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX, Substantially Equivalent on 2007-09-21. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
Recent devices under product code FMZ
view allMore clearances from Medix I.C.S.A.
view allAdverse events under product code FMZ
product code FMZ- Death
- 2
- Malfunction
- 457
- Other
- 1
- Total
- 460
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K070291
K-number listed on FDA's recall record- Z-0056-2017 — The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
- Z-1363-2016 — Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070291.
Data sourced from openFDA. This site is unofficial and independent of the FDA.