Device Classification Name |
warmer, infant radiant
|
510(k) Number |
K120937 |
Device Name |
SUNFLOWER WARNER |
Applicant |
ATOM MEDICAL CORPORATION |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
ATOM MEDICAL CORPORATION |
24301 WOODSAGE DRIVE |
BONITA SPRINGS,
FL
34134
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 880.5130
|
Classification Product Code |
|
Date Received | 03/28/2012 |
Decision Date | 07/06/2012 |
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
|
|
|