The following data is part of a premarket notification filed by Medix I.c.s.a. with the FDA for Medix Natal Care Intensive Care Incubator, Models-natal Care St-mx/lx/bx.
| Device ID | K070291 |
| 510k Number | K070291 |
| Device Name: | MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX |
| Classification | Incubator, Neonatal |
| Applicant | MEDIX I.C.S.A. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | James H Knauss |
| Correspondent | James H Knauss MEDIX I.C.S.A. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-30 |
| Decision Date | 2007-09-21 |
| Summary: | summary |