FDA 510(k)

Crystal Vision

K-Number: K163659 · 2017-10-30

Decision Date2017-10-30

Product CodeFYD

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Crystal Vision is a medical device manufactured by I.C Medical, Inc.. It received FDA 510(k) clearance on 2017-10-30 under approval number K163659. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Crystal Vision?

Crystal Vision is a medical device that received FDA 510(k) clearance on 2017-10-30. It is manufactured by I.C Medical, Inc.. The 510(k) number is K163659.

When was Crystal Vision approved by the FDA?

Crystal Vision received FDA 510(k) clearance on 2017-10-30, under approval number K163659.

What company makes Crystal Vision?

Crystal Vision is manufactured by I.C Medical, Inc..

What is the FDA product code for Crystal Vision?

The FDA product code for Crystal Vision is FYD.

Other Devices by I.C Medical, Inc.

K160160Non-Telescopic PenEvac

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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.