Decision Date2010-04-16
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
AMBU ASCOPE AND MONITOR 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 2010-04-16 under 510(k) number K093186. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AMBU ASCOPE AND MONITOR?
AMBU ASCOPE AND MONITOR is a medical device that received FDA 510(k) clearance on 2010-04-16. The listed applicant is Ambu A/S. The 510(k) number is K093186.
When did AMBU ASCOPE AND MONITOR receive FDA 510(k) clearance?
AMBU ASCOPE AND MONITOR received FDA 510(k) clearance on 2010-04-16, under 510(k) number K093186.
Who is the listed applicant for AMBU ASCOPE AND MONITOR?
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 ASCOPE AND MONITOR?
The FDA product code for AMBU ASCOPE AND MONITOR is BTR.
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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.