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FDA 510(k)

Cocoon Portable Handheld X-Ray System

K-Number: K173046 · 2017-10-26

ApplicantDexcowin Co., Ltd.
Decision Date2017-10-26
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Cocoon Portable Handheld X-Ray System is a medical device manufactured by Dexcowin Co., Ltd.. It received FDA 510(k) clearance on 2017-10-26 under approval number K173046. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cocoon Portable Handheld X-Ray System?

Cocoon Portable Handheld X-Ray System is a medical device that received FDA 510(k) clearance on 2017-10-26. It is manufactured by Dexcowin Co., Ltd.. The 510(k) number is K173046.

When was Cocoon Portable Handheld X-Ray System approved by the FDA?

Cocoon Portable Handheld X-Ray System received FDA 510(k) clearance on 2017-10-26, under approval number K173046.

What company makes Cocoon Portable Handheld X-Ray System?

Cocoon Portable Handheld X-Ray System is manufactured by Dexcowin Co., Ltd..

What is the FDA product code for Cocoon Portable Handheld X-Ray System?

The FDA product code for Cocoon Portable Handheld X-Ray System is MUH.

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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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