Device Classification Name |
Incubator, Neonatal
|
510(k) Number |
K152809 |
Device Name |
Giraffe Incubator Carestation CS1 |
Applicant |
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. |
8880 GORMAN ROAD |
LAUREL,
MD
20723
|
|
Applicant Contact |
KENNY BELLO |
Correspondent |
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. |
8880 GORMAN ROAD |
LAUREL,
MD
20723
|
|
Correspondent Contact |
KENNY BELLO |
Regulation Number | 880.5400
|
Classification Product Code |
|
Date Received | 09/28/2015 |
Decision Date | 12/31/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|