Device Classification Name |
Incubator, Neonatal
|
510(k) Number |
K993712 |
Device Name |
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM |
Applicant |
OHMEDA MEDICAL |
9065 GUILFORD RD. |
COLUMBIA,
MD
21046
|
|
Applicant Contact |
ALBERTO F PROFUMO |
Correspondent |
OHMEDA MEDICAL |
9065 GUILFORD RD. |
COLUMBIA,
MD
21046
|
|
Correspondent Contact |
ALBERTO F PROFUMO |
Regulation Number | 880.5400
|
Classification Product Code |
|
Date Received | 11/03/1999 |
Decision Date | 11/09/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|