Device Classification Name |
Incubator, Neonatal
|
510(k) Number |
K070291 |
Device Name |
MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX |
Applicant |
MEDIX I.C.S.A. |
11874 SOUTH EVELYN CIRCLE |
HOUSTON,
TX
77071
|
|
Applicant Contact |
JAMES H KNAUSS |
Correspondent |
MEDIX I.C.S.A. |
11874 SOUTH EVELYN CIRCLE |
HOUSTON,
TX
77071
|
|
Correspondent Contact |
JAMES H KNAUSS |
Regulation Number | 880.5400
|
Classification Product Code |
|
Date Received | 01/30/2007 |
Decision Date | 09/21/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|