Device Classification Name |
unit, neonatal phototherapy
|
510(k) Number |
K894129 |
Device Name |
BILIBLANKET PHOTOTHERAPY DEVICE |
Applicant |
OHMEDA MEDICAL |
9065 GUILFORD RD. |
COLUMBIA,
MD
21046
|
|
Applicant Contact |
ALBERTO PROFUMO |
Correspondent |
OHMEDA MEDICAL |
9065 GUILFORD RD. |
COLUMBIA,
MD
21046
|
|
Correspondent Contact |
ALBERTO PROFUMO |
Regulation Number | 880.5700
|
Classification Product Code |
|
Date Received | 06/12/1989 |
Decision Date | 09/28/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|