Device Classification Name |
Unit, Neonatal Phototherapy
|
510(k) Number |
K120168 |
Device Name |
LULLABY LED PHOTTHERAPY SYSTEM |
Applicant |
WIPRO GE HEALTHCARE PRIVATE, LTD. |
8880 GORMAN ROAD |
LAUREL,
MD
20723
|
|
Applicant Contact |
AGATA ANTHONY |
Correspondent |
WIPRO GE HEALTHCARE PRIVATE, LTD. |
8880 GORMAN ROAD |
LAUREL,
MD
20723
|
|
Correspondent Contact |
AGATA ANTHONY |
Regulation Number | 880.5700
|
Classification Product Code |
|
Date Received | 01/19/2012 |
Decision Date | 05/02/2012 |
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
|
|
|