FDA.report

510(k) K203749

Device
Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
Applicant
Ambu A/S
510(k) number
K203749
Product code
CBI
Decision
Substantially Equivalent (SESE)
Decision date
2021-05-03
Date received
2020-12-23
Regulation
868.5740
Classification name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Karina Matthiesen
Address
Baltorpbakken 13 Ballerup DK 2750 2750

FDA Registration Numbers

Source Documents

510(k) summary PDF

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