Device Classification Name |
Incubator, Neonatal
|
510(k) Number |
K102226 |
Device Name |
DUAL INCU I |
Applicant |
ATOM MEDICAL CORPORATION |
3-18-15 HONGO |
BUNKYO-KU, TOKYO,
JP
113-0033
|
|
Applicant Contact |
TSUYOSHI SUGINO |
Correspondent |
ATOM MEDICAL CORPORATION |
3-18-15 HONGO |
BUNKYO-KU, TOKYO,
JP
113-0033
|
|
Correspondent Contact |
TSUYOSHI SUGINO |
Regulation Number | 880.5400
|
Classification Product Code |
|
Date Received | 08/09/2010 |
Decision Date | 01/04/2011 |
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
|
|
|