Device Classification Name |
unit, neonatal phototherapy
|
510(k) Number |
K103589 |
Device Name |
NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM |
Applicant |
NATUS MEDICAL INCORPORATED |
5900 FIRST AVENUE SOUTH |
SEATTLE,
WA
98108
|
|
Applicant Contact |
JULIE FREED |
Correspondent |
NATUS MEDICAL INCORPORATED |
5900 FIRST AVENUE SOUTH |
SEATTLE,
WA
98108
|
|
Correspondent Contact |
JULIE FREED |
Regulation Number | 880.5700
|
Classification Product Code |
|
Date Received | 12/07/2010 |
Decision Date | 05/13/2011 |
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
|
|
|