Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K093186 |
Device Name |
AMBU ASCOPE AND MONITOR |
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 | 868.5730
|
Classification Product Code |
|
Date Received | 10/09/2009 |
Decision Date | 04/16/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|