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Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Am — Ambu A/S (510(k) K161656)

Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Am — Ambu A/S (510(k) K161656) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Am; Applicant: Ambu A/S;

Device nameAmbu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Am
ApplicantAmbu A/S
Clearance track510(k)
Submission numberK161656
DecisionSubstantially Equivalent
Decision date2016-09-01
Date received2016-06-16
Product codeEOQ
Device class2
Medical specialtyEar, Nose, Throat
Applicant locationDK
SourceopenFDA device

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