Decision Date2016-08-17
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Ambu USR, Ambu M 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 2016-08-17 under 510(k) number K160766. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ambu USR, Ambu M?
Ambu USR, Ambu M is a medical device that received FDA 510(k) clearance on 2016-08-17. The listed applicant is Ambu A/S. The 510(k) number is K160766.
When did Ambu USR, Ambu M receive FDA 510(k) clearance?
Ambu USR, Ambu M received FDA 510(k) clearance on 2016-08-17, under 510(k) number K160766.
Who is the listed applicant for Ambu USR, Ambu M?
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 USR, Ambu M?
The FDA product code for Ambu USR, Ambu M is FAJ.
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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.