Device Classification Name |
Warmer, Infant Radiant
|
510(k) Number |
K072157 |
Device Name |
MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) |
Applicant |
OHMEDA MEDICAL |
8880 GORMAN RD. |
LAUREL,
MD
20723
|
|
Applicant Contact |
AGATA SMIEJA |
Correspondent |
OHMEDA MEDICAL |
8880 GORMAN RD. |
LAUREL,
MD
20723
|
|
Correspondent Contact |
AGATA SMIEJA |
Regulation Number | 880.5130
|
Classification Product Code |
|
Date Received | 08/03/2007 |
Decision Date | 08/27/2007 |
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
|
Recalls |
CDRH Recalls
|
|
|