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FDA 510(k)

True HD 3MOS Camera System

K-Number: K161017 · 2016-05-09

Decision Date2016-05-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

True HD 3MOS Camera System is a medical device manufactured by Conmed Corporation. It received FDA 510(k) clearance on 2016-05-09 under approval number K161017. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the True HD 3MOS Camera System?

True HD 3MOS Camera System is a medical device that received FDA 510(k) clearance on 2016-05-09. It is manufactured by Conmed Corporation. The 510(k) number is K161017.

When was True HD 3MOS Camera System approved by the FDA?

True HD 3MOS Camera System received FDA 510(k) clearance on 2016-05-09, under approval number K161017.

What company makes True HD 3MOS Camera System?

True HD 3MOS Camera System is manufactured by Conmed Corporation.

What is the FDA product code for True HD 3MOS Camera System?

The FDA product code for True HD 3MOS Camera System is GCJ.

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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.