FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
K Number: K070291
·
Decision Sep 21, 2007
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
81
Applicant Total
6
Review Days
234
Basic Information
- Device Name
- MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX
- K Number
- K070291
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDIX I.C.S.A.
- Date Received
- January 30, 2007
- Decision Date
- September 21, 2007
- Product Code
- FMZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMZ | Incubator, Neonatal | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMZ), ordered by most recent decision date.
Giraffe Incubator Carestation CS1
FDA 510(k)
FDA Class 2
·General Hospital
Infant Incubator
FDA 510(k)
FDA Class 2
·General Hospital
Babyleo TN500
FDA 510(k)
FDA Class 2
·General Hospital
Isolette 8000 Plus
FDA 510(k)
FDA Class 2
·General Hospital
Isolette 8000 plus
FDA 510(k)
FDA Class 2
·General Hospital
Babyleo TN500
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by MEDIX I.C.S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K103735 | MEDILED MINI | Aug 15, 2011 | Substantially Equivalent |
| K083179 | MEDILED PHOTOTHERAPY LAMP | Feb 27, 2009 | Substantially Equivalent |
| K931529 | INFANT WARMER | Mar 11, 1994 | Substantially Equivalent |
| K931965 | MEDIX PHOTOTHERAPY LAMP | Dec 9, 1993 | Substantially Equivalent |
| K920049 | MEDIX PC-305 NEONATAL INCUBATOR | May 21, 1993 | Substantially Equivalent |