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FDA 510(k)

microTargeting Guideline 4000 5.0 System

K-Number: K183123 · 2018-12-20

ApplicantFHC, Inc.
Decision Date2018-12-20
Product CodeGZL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

microTargeting Guideline 4000 5.0 System is a medical device manufactured by FHC, Inc.. It received FDA 510(k) clearance on 2018-12-20 under approval 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. It is manufactured by FHC, Inc.. The 510(k) number is K183123.

When was microTargeting Guideline 4000 5.0 System approved by the FDA?

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

What company makes microTargeting Guideline 4000 5.0 System?

microTargeting Guideline 4000 5.0 System is manufactured by FHC, Inc..

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.

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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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