ManoScan System
K-Number: K151086 · 2016-04-28
ApplicantGiven Imaging , Ltd.
Decision Date2016-04-28
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
ManoScan System is a medical device manufactured by Given Imaging , Ltd.. It received FDA 510(k) clearance on 2016-04-28 under approval number K151086. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ManoScan System?
ManoScan System is a medical device that received FDA 510(k) clearance on 2016-04-28. It is manufactured by Given Imaging , Ltd.. The 510(k) number is K151086.
When was ManoScan System approved by the FDA?
ManoScan System received FDA 510(k) clearance on 2016-04-28, under approval number K151086.
What company makes ManoScan System?
ManoScan System is manufactured by Given Imaging , Ltd..
What is the FDA product code for ManoScan System?
The FDA product code for ManoScan System is FFX.
Related Clinical Trials
Other Devices by Given Imaging , Ltd.
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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.