FDA 510(k)

microTargeting Guideline 4000 5.0 System

K-Number: K183123 · 2018-12-20

Decision Date2018-12-20

Product CodeGZL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

microTargeting Guideline 4000 5.0 System is the device name listed in this FDA 510(k) record. The listed applicant is FHC, Inc.. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K183123. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the microTargeting Guideline 4000 5.0 System?

microTargeting Guideline 4000 5.0 System is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is FHC, Inc.. The 510(k) number is K183123.

When did microTargeting Guideline 4000 5.0 System receive FDA 510(k) clearance?

microTargeting Guideline 4000 5.0 System received FDA 510(k) clearance on 2018-12-20, under 510(k) number K183123.

Who is the listed applicant for microTargeting Guideline 4000 5.0 System?

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

What is the FDA product code for microTargeting Guideline 4000 5.0 System?

The FDA product code for microTargeting Guideline 4000 5.0 System is GZL.

Other records listing FHC, Inc. as applicant

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Official Source

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