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FDA 510(k)

Aquas Probes

K-Number: K190168 · 2019-03-14

ApplicantGenicon, Inc.
Decision Date2019-03-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aquas Probes is a medical device manufactured by Genicon, Inc.. It received FDA 510(k) clearance on 2019-03-14 under approval number K190168. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aquas Probes?

Aquas Probes is a medical device that received FDA 510(k) clearance on 2019-03-14. It is manufactured by Genicon, Inc.. The 510(k) number is K190168.

When was Aquas Probes approved by the FDA?

Aquas Probes received FDA 510(k) clearance on 2019-03-14, under approval number K190168.

What company makes Aquas Probes?

Aquas Probes is manufactured by Genicon, Inc..

What is the FDA product code for Aquas Probes?

The FDA product code for Aquas Probes is GEI.

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Official Source

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