MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
FDA 510(k) clearance K070291 · decided 2007-09-21
Clearance details
- K-number
- K070291
- Device name
- MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
- Applicant
- Medix I.C.S.A.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-30
- Decision date
- 2007-09-21
- Days to decision
- 234 days
- Clearance type
- Traditional
- Product code
- FMZ
- Device class
- 2
- Regulation number
- 880.5400
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1 recall (Z-0056-2017) | Natus Medical Incorporated | 2016-10-07 |
| Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator. recall (Z-1363-2016) | Natus Medical Incorporated | 2016-04-11 |