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FDA 510(k)

Crystal Vision

K-Number: K163659 · 2017-10-30

ApplicantI.C Medical, Inc.
Decision Date2017-10-30
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Crystal Vision is the device name listed in this FDA 510(k) record. The listed applicant is I.C Medical, Inc.. It received FDA 510(k) clearance on 2017-10-30 under 510(k) 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. The listed applicant is I.C Medical, Inc.. The 510(k) number is K163659.

When did Crystal Vision receive FDA 510(k) clearance?

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

Who is the listed applicant for Crystal Vision?

The FDA 510(k) record lists I.C Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Crystal Vision?

The FDA product code for Crystal Vision is FYD.

Other records listing I.C Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160160Non-Telescopic PenEvac

Related Devices (Code: FYD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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