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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging , Ltd.. It received FDA 510(k) clearance on 2016-04-28 under 510(k) 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. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K151086.

When did ManoScan System receive FDA 510(k) clearance?

ManoScan System received FDA 510(k) clearance on 2016-04-28, under 510(k) number K151086.

Who is the listed applicant for ManoScan System?

The FDA 510(k) record lists Given Imaging , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ManoScan System?

The FDA product code for ManoScan System is FFX.

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Official Source

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

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