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FDA 510(k)

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable

K-Number: K203749 · 2021-05-03

ApplicantAmbu A/S
Decision Date2021-05-03
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable is the device name listed in this FDA 510(k) record. The listed applicant is Ambu A/S. It received FDA 510(k) clearance on 2021-05-03 under 510(k) number K203749. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable?

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable is a medical device that received FDA 510(k) clearance on 2021-05-03. The listed applicant is Ambu A/S. The 510(k) number is K203749.

When did Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable receive FDA 510(k) clearance?

Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable received FDA 510(k) clearance on 2021-05-03, under 510(k) number K203749.

Who is the listed applicant for Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable?

The FDA 510(k) record lists Ambu A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable?

The FDA product code for Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable is CBI.

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Related Devices (Code: CBI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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