Device Classification Name |
tube, tracheal/bronchial, differential ventilation (w/wo connector)
|
510(k) Number |
K203749 |
Device Name |
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable |
Applicant |
Ambu A/S |
Baltorpbakken 13 |
Ballerup,
DK
2750
|
|
Applicant Contact |
Karina Matthiesen |
Correspondent |
Ambu Inc. |
6230 Old Dobbin Lane, Suite 250 |
Columbia,
MD
21045
|
|
Correspondent Contact |
Sanjay Parikh |
Regulation Number | 868.5740
|
Classification Product Code |
|
Date Received | 12/23/2020 |
Decision Date | 05/03/2021 |
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
|
|
|