Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K102824 |
Device Name |
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC |
Applicant |
AMBU A/S |
6740 BAYMEADOW DR. |
GLEN BURNIE,
MD
21060
|
|
Applicant Contact |
SANJAY PARIKH |
Correspondent |
AMBU A/S |
6740 BAYMEADOW DR. |
GLEN BURNIE,
MD
21060
|
|
Correspondent Contact |
SANJAY PARIKH |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 09/29/2010 |
Decision Date | 01/28/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|