Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K070247 |
Device Name |
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM |
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 | 868.5915
|
Classification Product Code |
|
Date Received | 01/25/2007 |
Decision Date | 04/20/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|